Recall archive / FDA device enforcement

NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Descript... — FDA record Z-0319-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 29, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM CPA2-010 PA1051-010 PACKAGED END CAP, 8.5/ 10.7MM, +10MM CPA2-015 PA1051-015 PACKAGED END CAP, 8.5/ 10.7MM, +15MM CPA2-020 PA1051-020 PACKAGED END CAP, 8.5/ 10.7MM, +20MM CPA3-000 PA1052-000 PACKAGED END CAP, 12.5MM , +0MM CPA3-005 PA1052-005 PACKAGED END CAP, 12.5MM , +5MM CPA3-010 PA1052-010 PACKAGED END CAP, 12.5MM , +10MM CPA3-015 PA1052-015 PACKAGED END CAP, 12.5MM , +15MM CPA3-020 PA1052-020 PACKAGED END CAP, 12.5MM , +20MM HEC1-000 PA0709-000 END CAP, 0MM HUMERAL NAIL HEC2-000 PA0709-002 END CAP, 2MM HUMERAL NAIL HEC3-000 PA0709-005 END CAP, 5MM HUMERAL NAIL HEC4-000 PA0709-010 END CAP, 10MM HUMERAL NAIL HEC5-000 PA0709-015 END CAP, 15MM HUMERAL NAIL LSB3-020 PP1699-020 Locking Screw, 3.5mm x 2 0mm LSB3-025 PP1699-025 Locking Screw, 3.5mm x 2 5mm LSB3-030 PP1699-030 Locking Screw, 3.5mm x 3 0mm LSB3-035 PP1699-035 Locking Screw, 3.5mm x 3 5mm LSB3-040 PP1699-040 Locking Screw, 3.5mm x 4 0mm LSB3-045 PP1699-045 Locking Screw, 3.5mm x 4 5mm LSB3-050 PP1699-050 Locking Screw, 3.5mm x 5 0mm LSB3-055 PP1699-055 Locking Screw, 3.5mm x 5 5mm LSB3-060 PP1699-060 Locking Screw, 3.5mm x 6 0mm LSB3-200-S PA1220-020 3.5mm x 20mm Screw, Peg LSB3-250-S PA1220-025 3.5mm x 25mm Screw, Peg LSB3-300-S PA1220-030 3.5mm x 30mm Screw, Peg LSB3-350-S PA1220-035 3.5mm x 35mm Screw, Peg LSB3-400-S PA1220-040 3.5mm x 40mm Screw, Peg LSB3-450-S PA1220-045 3.5mm x 45mm Screw, Peg LSB3-500-S PA1220-050 3.5mm x 50mm Screw, Peg LSB3-550-S PA1220-055 3.5mm x 55mm Screw, Peg LSB3-600-S PA1220-060 3.5mm x 60mm Screw, Peg LSB4-020 PP1425-020 Locking Screw, 4.0mm x 20mm LSB4-025 PP1425-025 Locking Screw, 4.0mm x 25mm LSB4-030 PP1425-030 Locking Screw, 4.0mm x 30mm LSB4-035 PP1425-035 Locking Screw, 4.0mm x 35mm LSB4-040 PP1425-040 Locking Screw, 4.0mm x 40mm LSB4-045 PP1425-045 Locking Screw, 4.0mm x 45mm LSB4-050 PP1425-050 Locking Screw, 4.0mm x 50mm LSB4-055 PP1425-055 Locking Screw, 4.0mm x 55mm LSB4-060 PP1425-060 Locking Screw, 4.0mm x 60mm LSB5-020 PP1426-020 Locking Screw, 5.0mm x 20mm LSB5-025 PP1426-025 Locking Screw, 5.0mm x 25mm LSB5-030 PP1426-030 Locking Screw, 5.0mm x 30mm LSB5-035 PP1426-035 Locking Screw, 5.0mm x 35mm LSB5-040 PP1426-040 Locking Screw, 5.0mm x 40mm LSB5-045 PP1426-045 Locking Screw, 5.0mm x 45mm LSB5-050 PP1426-050 Locking Screw, 5.0mm x 50mm LSB5-055 PP1426-055 Locking Screw, 5.0mm x 55mm LSB5-060 PP1426-060 Locking Screw, 5.0mm x 60mm LSB5-065 PP1426-065 Locking Screw, 5.0mm x 65mm LSB5-070 PP1426-070 Locking Screw, 5.0mm x 70mm LSB5-075 PP1426-075 Locking Screw, 5.0mm x 75mm LSC4-020 PP1794-020 Locking Screw, 4.0mm x 2 0mm LSC4-025 PP1794-025 Locking Screw, 4.0mm x 2 5mm LSC4-030 PP1794-030 Locking Screw, 4.0mm x 3 0mm LSC4-035 PP1794-035 Locking Screw, 4.0mm x 3 5mm LSC4-040 P...
Reason: The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.
Classification: Class II
Recalling firm: NuVasive Specialized Orthopedics, Inc.
Quantity: Total 11,861 devices (IMLL=10,657 and Short=1,204)
Agency-reported status: Ongoing
Source record identifier: Z-0319-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	All Lots manufactured between April 2015 to February 2021 UDI/Model No./Item No./Product Description: 812258020002 CPA1-000 PA0382-001 End Cap 887517001139 CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM 887517001146 CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM 887517001153 CPA2-010 PA1051-010 PACKAGED END CAP, 8.5/ 10.7MM, +10MM 887517001160 CPA2-015 PA1051-015 PACKAGED END CAP, 8.5/ 10.7MM, +15MM 887517001177 CPA2-020 PA1051-020 PACKAGED END CAP, 8.5/ 10.7MM, +20MM 887517001184 CPA3-000 PA1052-000 PACKAGED END CAP, 12.5MM , +0MM 887517001191 CPA3-005 PA1052-005 PACKAGED END CAP, 12.5MM , +5MM 887517001207 CPA3-010 PA1052-010 PACKAGED END CAP, 12.5MM , +10MM 887517001214 CPA3-015 PA1052-015 PACKAGED END CAP, 12.5MM , +15MM 887517001221 CPA3-020 PA1052-020 PACKAGED END CAP, 12.5MM , +20MM 812258028121 HEC1-000 PA0709-000 END CAP, 0MM HUMERAL NAIL 812258028138 HEC2-000 PA0709-002 END CAP, 2MM HUMERAL NAIL 812258028145 HEC3-000 PA0709-005 END CAP, 5MM HUMERAL NAIL 812258028152 HEC4-000 PA0709-010 END CAP, 10MM HUMERAL NAIL 812258028169 HEC5-000 PA0709-015 END CAP, 15MM HUMERAL NAIL 812258021337 LSB3-020 PP1699-020 Locking Screw, 3.5mm x 2 0mm 812258021344 LSB3-025 PP1699-025 Locking Screw, 3.5mm x 2 5mm 812258021351 LSB3-030 PP1699-030 Locking Screw, 3.5mm x 3 0mm 812258021368 LSB3-035 PP1699-035 Locking Screw, 3.5mm x 3 5mm 812258021375 LSB3-040 PP1699-040 Locking Screw, 3.5mm x 4 0mm 812258021382 LSB3-045 PP1699-045 Locking Screw, 3.5mm x 4 5mm 812258021399 LSB3-050 PP1699-050 Locking Screw, 3.5mm x 5 0mm 812258021405 LSB3-055 PP1699-055 Locking Screw, 3.5mm x 5 5mm 812258021412 LSB3-060 PP1699-060 Locking Screw, 3.5mm x 6 0mm 00887517029027 LSB3-200-S PA1220-020 3.5mm x 20mm Screw, Peg 00887517029010 LSB3-250-S PA1220-025 3.5mm x 25mm Screw, Peg 00887517029003 LSB3-300-S PA1220-030 3.5mm x 30mm Screw, Peg 00887517028990 LSB3-350-S PA1220-035 3.5mm x 35mm Screw, Peg 00887517028983 LSB3-400-S PA1220-040 3.5mm x 40mm Screw, Peg 00887517028976 LSB3-450-S PA1220-045 3.5mm x 45mm Screw, Peg 00887517028969 LSB3-500-S PA1220-050 3.5mm x 50mm Screw, Peg 00887517028952 LSB3-550-S PA1220-055 3.5mm x 55mm Screw, Peg 00887517028945 LSB3-600-S PA1220-060 3.5mm x 60mm Screw, Peg 856719002763 LSB4-020 PP1425-020 Locking Screw, 4.0mm x 20mm 856719002770 LSB4-025 PP1425-025 Locking Screw, 4.0mm x 25mm 856719002787 LSB4-030 PP1425-030 Locking Screw, 4.0mm x 30mm 856719002794 LSB4-035 PP1425-035 Locking Screw, 4.0mm x 35mm 856719002800 LSB4-040 PP1425-040 Locking Screw, 4.0mm x 40mm 856719002817 LSB4-045 PP1425-045 Locking Screw, 4.0mm x 45mm 856719002824 LSB4-050 PP1425-050 Locking Screw, 4.0mm x 50mm 856719002831 LSB4-055 PP1425-055 Locking Screw, 4.0mm x 55mm 856719002848 LSB4-060 PP1425-060 Locking Screw, 4.0mm x 60mm 856719002886 LSB5-020 PP1426-020 Locking Screw, 5.0mm x 20mm 856719002893 LSB5-025 PP1426-025 Locking Screw, 5.0mm x 25mm 856719002909 LSB5-030 PP1426-030 Locking Screw, 5.0mm x 30mm 856719002916 LSB5-035 PP1426-035 Locking Screw, 5.0mm x 35mm 856719002923 LSB5-040 PP1426-040 Locking Screw, 5.0mm x 40mm 856719002930 LSB5-045 PP1426-045 Locking Screw, 5.0mm x 45mm 856719002947 LSB5-050 PP1426-050 Locking Screw, 5.0mm x 50mm 856719002954 LSB5-055 PP1426-055 Locking Screw, 5.0mm x 55mm 856719002961 LSB5-060 PP1426-060 Locking Screw, 5.0mm x 60mm 856719002978 LSB5-065 PP1426-065 Locking Screw, 5.0mm x 65mm 856719002985 LSB5-070 PP1426-070 Locking Screw, 5.0mm x 70mm 856719002992 LSB5-075 PP1426-075 Locking Screw, 5.0mm x 75mm 812258021429 LSC4-020 PP1794-020 Locking Screw, 4.0mm x 2 0mm 812258021436 LSC4-025 PP1794-025 Locking Screw, 4.0mm x 2 5mm 812258021443 LSC4-030 PP1794-030 Locking Screw, 4.0mm x 3 0mm 812258021450 LSC4-035 PP1794-035 Locking Screw, 4.0mm x 3 5mm 812258021467 LSC4-040 PP1794-040 Locking Screw, 4.0mm x 4 0mm 812258021474 LSC4-045 PP1794-045 Locking Screw, 4.0mm x 4 5mm 812258021481 LSC4-050 PP1794-050 Locking Screw, 4.0mm x 5 0mm 812258021498 LSC4-055 PP1794-055 Locking Screw, 4.0mm x 5 5mm 812258021504 LSC4-060 PP1794-060 Locking Screw, 4.0mm x 6 0mm 00887517028938 LSC4-200-S PA1221-020 4.0mm x 20mm Screw, Peg 00887517028921 LSC4-250-S PA1221-025 4.0mm x 25mm Screw, Peg 00887517028914 LSC4-300-S PA1221-030 4.0mm x 30mm Screw, Peg 00887517028907 LSC4-350-S PA1221-035 4.0mm x 35mm Screw, Peg 00887517028891 LSC4-400-S PA1221-040 4.0mm x 40mm Screw, Peg 00887517028884 LSC4-450-S PA1221-045 4.0mm x 45mm Screw, Peg 00887517028877 LSC4-500-S PA1221-050 4.0mm x 50mm Screw, Peg 00887517028860 LSC4-550-S PA1221-055 4.0mm x 55mm Screw, Peg 00887517028853 LSC4-600-S PA1221-060 4.0mm x 60mm Screw, Peg 812258021511 LSC5-020 PP1742-020 Locking Screw, 5.0mm x 2 0mm 812258021528 LSC5-025 PP1742-025 Locking Screw, 5.0mm x 2 5mm 812258021535 LSC5-030 PP1742-030 Locking Screw, 5.0mm x 3 0mm 812258021542 LSC5-035 PP1742-035 Locking Screw, 5.0mm x 3 5mm 812258021559 LSC5-040 PP1742-040 Locking Screw, 5.0mm x 4 0mm 812258021566 LSC5-045 PP1742-045 Locking Screw, 5.0mm x 4 5mm 812258021573 LSC5-050 PP1742-050 Locking Screw, 5.0mm x 5 0mm 812258021580 LSC5-055 PP1742-055 Locking Screw, 5.0mm x 5 5mm 812258021597 LSC5-060 PP1742-060 Locking Screw, 5.0mm x 6 0mm 812258021603 LSC5-065 PP1742-065 Locking Screw, 5.0mm x 6 5mm 812258021610 LSC5-070 PP1742-070 Locking Screw, 5.0mm x 7 0mm 812258021627 LSC5-075 PP1742-075 Locking Screw, 5.0mm x 7 5mm 00887517028846 LSC5-200-S PA1222-020 5.0mm x 20mm Screw, Peg 00887517028839 LSC5-250-S PA1222-025 5.0mm x 25mm Screw, Peg 00887517028822 LSC5-300-S PA1222-030 5.0mm x 30mm Screw, Peg 00887517028815 LSC5-350-S PA1222-035 5.0mm x 35mm Screw, Peg 00887517028808 LSC5-400-S PA1222-040 5.0mm x 40mm Screw, Peg 00887517028792 LSC5-450-S PA1222-045 5.0mm x 45mm Screw, Peg 00887517028785 LSC5-500-S PA1222-050 5.0mm x 50mm Screw, Peg 00887517028778 LSC5-550-S PA1222-055 5.0mm x 55mm Screw, Peg 00887517028761 LSC5-600-S PA1222-060 5.0mm x 60mm Screw, Peg 00887517028754 LSC5-650-S PA1222-065 5.0mm x 65mm Screw, Peg 00887517028747 LSC5-700-S PA1222-070 5.0mm x 70mm Screw, Peg 00887517028730 LSC5-750-S PA1222-075 5.0mm x 75mm Screw, Peg 812258026073 P10.7-30H170 PA0676-30H170 Retrograde Feumr 10 Ben d 10.7MM X 170MM 812258026134 P10.7-30J160 PA0676-30J160 Antegrade Tibia 10 Bend 10.7MM X 160MM 812258026196 P10.7-30K170 PA0676-30K170 Antegrade Femur Troch 10 Bend 10.7MM X 170MM 812258026257 P10.7-30U170 PA0676-30U170 Universal Femur 10.7MM X 170MM 812258020057 P10.7-50A215 PA0411-50A215 Retrograde Femur 10deg, 10.7mm x 215mm 812258020064 P10.7-50A230 PA0411-50A230 Retrograde Femur 10deg, 10.7mm x 230mm 812258020231 P10.7-50B215 PA0411-50B215 Ante Femur Piriformis, 1 0.7mm x 215mm 812258020248 P10.7-50B230 PA0411-50B230 Ante Femur Piriformis, 1 0.7mm x 230mm 812258020422 P10.7-50C195 PA0411-50C195 Antegrade Tibia, 10.7mm x 195mm 812258020439 P10.7-50C215 PA0411-50C215 Antegrade Tibia, 10.7mm x 215mm 812258020446 P10.7-50C230 PA0411-50C230 Antegrade Tibia, 10.7mm x 230mm 812258020620 P10.7-50D215 PA0411-50D215 Ante Femur (Troch), 10.7 mm x 215mm 812258020637 P10.7-50D230 PA0411-50D230 Ante Femur (Troch), 10.7 mm x 230mm 00887517937254 P10.7-50E195 PA0411-50E195 Retrograde Femur Straigh t, 10.7mm x 195mm 812258020804 P10.7-50E215 PA0411-50E215 Retrograde Femur Straigh t, 10.7mm x 215mm 812258020811 P10.7-50E230 PA0411-50E230 Retrograde Femur Straigh t, 10.7mm x 230mm 812258026080 P10.7-50H190 PA0676-50H190 Retrograde Femur 10 Ben d 10.7MM X 190MM 812258026141 P10.7-50J180 PA0676-50J180 Antegrade Tibia 10 Bend 10.7MM X 180MM 812258026202 P10.7-50K190 PA0676-50K190 Antegrade Femur Troch 10 Bend10.7MM X 190MM 00887517937261 P10.7-50M160 PA0902-50M160 Antegrade Femur Troch 10 Bend 10.7mm X 160mm 812258028244 P10.7-50M175 PA0902-50M175 Antegrade Femur Troch 10 Bend 10.7mm X 175mm 812258028268 P10.7-50N160 PA0902-50N160 Universal Femur 10.7mm X 160mm 00887517937278 P10.7-50P160 PA0902-50P160 Retrograde Femur 10 Ben d 10.7mm x 160 mm 812258028282 P10.7-50P175 PA0902-50P175 Retrograde Femur 10 Bend 10.7mm x 175mm 00887517937285 P10.7-50Q150 PA0902-50Q150 Antegrade Tibia 10 Bend 10.7mm X 150mm 812258028220 P10.7-50Q155 PA0902-50Q155 Antegrade Tibia 10 Bend 10.7mm X 155mm 812258026264 P10.7-50U190 PA0676-50U190 Universal Femur 10.7MM X 190MM 887517934819 P10.7-50V215 PA0411-50V215 Retrograde Femur 10deg, 10.7mm x 215mm 887517934826 P10.7-50V230 PA0411-50V230 Retrograde Femur 10deg, 10.7mm x 230mm 887517934833 P10.7-50X215 PA0411-50X215 Retrograde Femur Straigh t, 10.7mm x 215mm 887517934840 P10.7-50X230 PA0411-50X230 Retrograde Femur Straigh t, 10.7mm x 230mm 812258020071 P10.7-80A245 PA0411-80A245 Retrograde Femur 10deg, 10.7mm x 245mm 812258020088 P10.7-80A275 PA0411-80A275 Retrograde Femur 10deg, 10.7mm x 275mm 812258020095 P10.7-80A305 PA0411-80A305 Retrograde Femur 10deg, 10.7mm x 305mm 812258020101 P10.7-80A335 PA0411-80A335 Retrograde Femur 10deg, 10.7mm x 335mm 812258020118 P10.7-80A365 PA0411-80A365 Retrograde Femur 10deg, 10.7mm x 365mm 812258020255 P10.7-80B245 PA0411-80B245 Ante Femur Piriformis, 1 0.7mm x 245mm 812258020262 P10.7-80B275 PA0411-80B275 Ante Femur Piriformis, 1 0.7mm x 275mm 812258020279 P10.7-80B305 PA0411-80B305 Ante Femur Piriformis, 1 0.7mm x 305mm 812258020286 P10.7-80B335 PA0411-80B335 Ante Femur Piriformis, 1 0.7mm x 335mm 812258020293 P10.7-80B365 PA0411-80B365 Ante Femur Piriformis, 1 0.7mm x 365mm 812258020453 P10.7-80C245 PA0411-80C245 Antegrade Tibia, 10.7mm x 245mm 812258020460 P10.7-80C275 PA0411-80C275 Antegrade Tibia, 10.7mm x 275mm 812258020477 P10.7-80C305 PA0411-80C305 Antegrade Tibia, 10.7mm x 305mm 812258020484 P10.7-80C335 PA0411-80C335 Antegrade Tibia, 10.7mm x 335mm 812258020491 P10.7-80C365 PA0411-80C365 Antegrade Tibia, 10.7mm x 365mm 812258020644 P10.7-80D245 PA0411-80D245 Ante Femur (Troch), 10.7 mm x 245mm 812258020651 P10.7-80D275 PA0411-80D275 Ante Femur (Troch), 10.7 mm x 275mm 812258020668 P10.7-80D305 PA0411-80D305 Ante Femur (Troch), 10.7 mm x 305mm 812258020675 P10.7-80D335 PA0411-80D335 Ante Femur (Troch), 10.7 mm x 335mm 812258020682 P10.7-80D365 PA0411-80D365 Ante Femur (Troch), 10.7 mm x 365mm 812258020828 P10.7-80E245 PA0411-80E245 Retrograde Femur Straigh t, 10.7mm x 245mm 812258020835 P10.7-80E275 PA0411-80E275 Retrograde Femur Straigh t, 10.7mm x 275mm 812258020842 P10.7-80E305 PA0411-80E305 Retrograde Femur Straigh t, 10.7mm x 305mm 812258020859 P10.7-80E335 PA0411-80E335 Retrograde Femur Straigh t, 10.7mm x 335mm 812258020866 P10.7-80E365 PA0411-80E365 Retrograde Femur Straigh t, 10.7mm x 365mm 887517934857 P10.7-80V245 PA0411-80V245 Retrograde Femur 10deg, 10.7mm x 245mm 887517934864 P10.7-80V275 PA0411-80V275 Retrograde Femur 10deg, 10.7mm x 275mm 887517934871 P10.7-80V305 PA0411-80V305 Retrograde Femur 10deg, 10.7mm x 305mm 887517934888 P10.7-80V335 PA0411-80V335 Retrograde Femur 10deg, 10.7mm x 335mm 887517934895 P10.7-80V365 PA0411-80V365 Retrograde Femur 10deg, 10.7mm x 365mm 887517935502 P10.7-80X245 PA0411-80X245 Retrograde Femur Straigh t, 10.7mm x 245mm 887517935519 P10.7-80X275 PA0411-80X275 Retrograde Femur Straigh t, 10.7mm x 275mm 887517935526 P10.7-80X305 PA0411-80X305 Retrograde Femur Straigh t, 10.7mm x 305mm 887517935533 P10.7-80X335 PA0411-80X335 Retrograde Femur Straigh t, 10.7mm x 335mm 887517935540 P10.7-80X365 PA0411-80X365 Retrograde Femur Straigh t, 10.7mm x 365mm 812258026097 P12.5-30H170 PA0677-30H170 Retrograde Femur 10 Ben d 12.5MM X 170MM 812258026158 P12.5-30J160 PA0677-30J160 Antegrade Tibia 10 Bend 12.5MM X 160MM 812258026219 P12.5-30K170 PA0677-30K170 Antegrade Femur Troch 10 Bend 12.5MM X 170MM 812258026271 P12.5-30U170 PA0677-30U170 Universal Femur 12.5MM 1 70MM 812258020125 P12.5-50A215 PA0417-50A215 Retrograde Femur 10deg, 12.5mm x 215mm 812258020132 P12.5-50A230 PA0417-50A230 Retrograde Femur 10deg, 12.5mm x 230mm 812258020309 P12.5-50B215 PA0417-50B215 Ante Femur Piriformis, 1 2.5mm x 215mm 812258020316 P12.5-50B230 PA0417-50B230 Ante Femur Piriformis, 1 2.5mm x 230mm 812258020507 P12.5-50C195 PA0417-50C195 Antegrade Tibia, 12.5mm x 1...

Label field

Details supplied by the agency

Lot, code or applicability

All Lots manufactured between April 2015 to February 2021 UDI/Model No./Item No./Product Description: 812258020002 CPA1-000 PA0382-001 End Cap 887517001139 CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM 887517001146 CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM 887517001153 CPA2-010 PA1051-010 PACKAGED END CAP, 8.5/ 10.7MM, +10MM 887517001160 CPA2-015 PA1051-015 PACKAGED END CAP, 8.5/ 10.7MM, +15MM 887517001177 CPA2-020 PA1051-020 PACKAGED END CAP, 8.5/ 10.7MM, +20MM 887517001184 CPA3-000 PA1052-000 PACKAGED END CAP, 12.5MM , +0MM 887517001191 CPA3-005 PA1052-005 PACKAGED END CAP, 12.5MM , +5MM 887517001207 CPA3-010 PA1052-010 PACKAGED END CAP, 12.5MM , +10MM 887517001214 CPA3-015 PA1052-015 PACKAGED END CAP, 12.5MM , +15MM 887517001221 CPA3-020 PA1052-020 PACKAGED END CAP, 12.5MM , +20MM 812258028121 HEC1-000 PA0709-000 END CAP, 0MM HUMERAL NAIL 812258028138 HEC2-000 PA0709-002 END CAP, 2MM HUMERAL NAIL 812258028145 HEC3-000 PA0709-005 END CAP, 5MM HUMERAL NAIL 812258028152 HEC4-000 PA0709-010 END CAP, 10MM HUMERAL NAIL 812258028169 HEC5-000 PA0709-015 END CAP, 15MM HUMERAL NAIL 812258021337 LSB3-020 PP1699-020 Locking Screw, 3.5mm x 2 0mm 812258021344 LSB3-025 PP1699-025 Locking Screw, 3.5mm x 2 5mm 812258021351 LSB3-030 PP1699-030 Locking Screw, 3.5mm x 3 0mm 812258021368 LSB3-035 PP1699-035 Locking Screw, 3.5mm x 3 5mm 812258021375 LSB3-040 PP1699-040 Locking Screw, 3.5mm x 4 0mm 812258021382 LSB3-045 PP1699-045 Locking Screw, 3.5mm x 4 5mm 812258021399 LSB3-050 PP1699-050 Locking Screw, 3.5mm x 5 0mm 812258021405 LSB3-055 PP1699-055 Locking Screw, 3.5mm x 5 5mm 812258021412 LSB3-060 PP1699-060 Locking Screw, 3.5mm x 6 0mm 00887517029027 LSB3-200-S PA1220-020 3.5mm x 20mm Screw, Peg 00887517029010 LSB3-250-S PA1220-025 3.5mm x 25mm Screw, Peg 00887517029003 LSB3-300-S PA1220-030 3.5mm x 30mm Screw, Peg 00887517028990 LSB3-350-S PA1220-035 3.5mm x 35mm Screw, Peg 00887517028983 LSB3-400-S PA1220-040 3.5mm x 40mm Screw, Peg 00887517028976 LSB3-450-S PA1220-045 3.5mm x 45mm Screw, Peg 00887517028969 LSB3-500-S PA1220-050 3.5mm x 50mm Screw, Peg 00887517028952 LSB3-550-S PA1220-055 3.5mm x 55mm Screw, Peg 00887517028945 LSB3-600-S PA1220-060 3.5mm x 60mm Screw, Peg 856719002763 LSB4-020 PP1425-020 Locking Screw, 4.0mm x 20mm 856719002770 LSB4-025 PP1425-025 Locking Screw, 4.0mm x 25mm 856719002787 LSB4-030 PP1425-030 Locking Screw, 4.0mm x 30mm 856719002794 LSB4-035 PP1425-035 Locking Screw, 4.0mm x 35mm 856719002800 LSB4-040 PP1425-040 Locking Screw, 4.0mm x 40mm 856719002817 LSB4-045 PP1425-045 Locking Screw, 4.0mm x 45mm 856719002824 LSB4-050 PP1425-050 Locking Screw, 4.0mm x 50mm 856719002831 LSB4-055 PP1425-055 Locking Screw, 4.0mm x 55mm 856719002848 LSB4-060 PP1425-060 Locking Screw, 4.0mm x 60mm 856719002886 LSB5-020 PP1426-020 Locking Screw, 5.0mm x 20mm 856719002893 LSB5-025 PP1426-025 Locking Screw, 5.0mm x 25mm 856719002909 LSB5-030 PP1426-030 Locking Screw, 5.0mm x 30mm 856719002916 LSB5-035 PP1426-035 Locking Screw, 5.0mm x 35mm 856719002923 LSB5-040 PP1426-040 Locking Screw, 5.0mm x 40mm 856719002930 LSB5-045 PP1426-045 Locking Screw, 5.0mm x 45mm 856719002947 LSB5-050 PP1426-050 Locking Screw, 5.0mm x 50mm 856719002954 LSB5-055 PP1426-055 Locking Screw, 5.0mm x 55mm 856719002961 LSB5-060 PP1426-060 Locking Screw, 5.0mm x 60mm 856719002978 LSB5-065 PP1426-065 Locking Screw, 5.0mm x 65mm 856719002985 LSB5-070 PP1426-070 Locking Screw, 5.0mm x 70mm 856719002992 LSB5-075 PP1426-075 Locking Screw, 5.0mm x 75mm 812258021429 LSC4-020 PP1794-020 Locking Screw, 4.0mm x 2 0mm 812258021436 LSC4-025 PP1794-025 Locking Screw, 4.0mm x 2 5mm 812258021443 LSC4-030 PP1794-030 Locking Screw, 4.0mm x 3 0mm 812258021450 LSC4-035 PP1794-035 Locking Screw, 4.0mm x 3 5mm 812258021467 LSC4-040 PP1794-040 Locking Screw, 4.0mm x 4 0mm 812258021474 LSC4-045 PP1794-045 Locking Screw, 4.0mm x 4 5mm 812258021481 LSC4-050 PP1794-050 Locking Screw, 4.0mm x 5 0mm 812258021498 LSC4-055 PP1794-055 Locking Screw, 4.0mm x 5 5mm 812258021504 LSC4-060 PP1794-060 Locking Screw, 4.0mm x 6 0mm 00887517028938 LSC4-200-S PA1221-020 4.0mm x 20mm Screw, Peg 00887517028921 LSC4-250-S PA1221-025 4.0mm x 25mm Screw, Peg 00887517028914 LSC4-300-S PA1221-030 4.0mm x 30mm Screw, Peg 00887517028907 LSC4-350-S PA1221-035 4.0mm x 35mm Screw, Peg 00887517028891 LSC4-400-S PA1221-040 4.0mm x 40mm Screw, Peg 00887517028884 LSC4-450-S PA1221-045 4.0mm x 45mm Screw, Peg 00887517028877 LSC4-500-S PA1221-050 4.0mm x 50mm Screw, Peg 00887517028860 LSC4-550-S PA1221-055 4.0mm x 55mm Screw, Peg 00887517028853 LSC4-600-S PA1221-060 4.0mm x 60mm Screw, Peg 812258021511 LSC5-020 PP1742-020 Locking Screw, 5.0mm x 2 0mm 812258021528 LSC5-025 PP1742-025 Locking Screw, 5.0mm x 2 5mm 812258021535 LSC5-030 PP1742-030 Locking Screw, 5.0mm x 3 0mm 812258021542 LSC5-035 PP1742-035 Locking Screw, 5.0mm x 3 5mm 812258021559 LSC5-040 PP1742-040 Locking Screw, 5.0mm x 4 0mm 812258021566 LSC5-045 PP1742-045 Locking Screw, 5.0mm x 4 5mm 812258021573 LSC5-050 PP1742-050 Locking Screw, 5.0mm x 5 0mm 812258021580 LSC5-055 PP1742-055 Locking Screw, 5.0mm x 5 5mm 812258021597 LSC5-060 PP1742-060 Locking Screw, 5.0mm x 6 0mm 812258021603 LSC5-065 PP1742-065 Locking Screw, 5.0mm x 6 5mm 812258021610 LSC5-070 PP1742-070 Locking Screw, 5.0mm x 7 0mm 812258021627 LSC5-075 PP1742-075 Locking Screw, 5.0mm x 7 5mm 00887517028846 LSC5-200-S PA1222-020 5.0mm x 20mm Screw, Peg 00887517028839 LSC5-250-S PA1222-025 5.0mm x 25mm Screw, Peg 00887517028822 LSC5-300-S PA1222-030 5.0mm x 30mm Screw, Peg 00887517028815 LSC5-350-S PA1222-035 5.0mm x 35mm Screw, Peg 00887517028808 LSC5-400-S PA1222-040 5.0mm x 40mm Screw, Peg 00887517028792 LSC5-450-S PA1222-045 5.0mm x 45mm Screw, Peg 00887517028785 LSC5-500-S PA1222-050 5.0mm x 50mm Screw, Peg 00887517028778 LSC5-550-S PA1222-055 5.0mm x 55mm Screw, Peg 00887517028761 LSC5-600-S PA1222-060 5.0mm x 60mm Screw, Peg 00887517028754 LSC5-650-S PA1222-065 5.0mm x 65mm Screw, Peg 00887517028747 LSC5-700-S PA1222-070 5.0mm x 70mm Screw, Peg 00887517028730 LSC5-750-S PA1222-075 5.0mm x 75mm Screw, Peg 812258026073 P10.7-30H170 PA0676-30H170 Retrograde Feumr 10 Ben d 10.7MM X 170MM 812258026134 P10.7-30J160 PA0676-30J160 Antegrade Tibia 10 Bend 10.7MM X 160MM 812258026196 P10.7-30K170 PA0676-30K170 Antegrade Femur Troch 10 Bend 10.7MM X 170MM 812258026257 P10.7-30U170 PA0676-30U170 Universal Femur 10.7MM X 170MM 812258020057 P10.7-50A215 PA0411-50A215 Retrograde Femur 10deg, 10.7mm x 215mm 812258020064 P10.7-50A230 PA0411-50A230 Retrograde Femur 10deg, 10.7mm x 230mm 812258020231 P10.7-50B215 PA0411-50B215 Ante Femur Piriformis, 1 0.7mm x 215mm 812258020248 P10.7-50B230 PA0411-50B230 Ante Femur Piriformis, 1 0.7mm x 230mm 812258020422 P10.7-50C195 PA0411-50C195 Antegrade Tibia, 10.7mm x 195mm 812258020439 P10.7-50C215 PA0411-50C215 Antegrade Tibia, 10.7mm x 215mm 812258020446 P10.7-50C230 PA0411-50C230 Antegrade Tibia, 10.7mm x 230mm 812258020620 P10.7-50D215 PA0411-50D215 Ante Femur (Troch), 10.7 mm x 215mm 812258020637 P10.7-50D230 PA0411-50D230 Ante Femur (Troch), 10.7 mm x 230mm 00887517937254 P10.7-50E195 PA0411-50E195 Retrograde Femur Straigh t, 10.7mm x 195mm 812258020804 P10.7-50E215 PA0411-50E215 Retrograde Femur Straigh t, 10.7mm x 215mm 812258020811 P10.7-50E230 PA0411-50E230 Retrograde Femur Straigh t, 10.7mm x 230mm 812258026080 P10.7-50H190 PA0676-50H190 Retrograde Femur 10 Ben d 10.7MM X 190MM 812258026141 P10.7-50J180 PA0676-50J180 Antegrade Tibia 10 Bend 10.7MM X 180MM 812258026202 P10.7-50K190 PA0676-50K190 Antegrade Femur Troch 10 Bend10.7MM X 190MM 00887517937261 P10.7-50M160 PA0902-50M160 Antegrade Femur Troch 10 Bend 10.7mm X 160mm 812258028244 P10.7-50M175 PA0902-50M175 Antegrade Femur Troch 10 Bend 10.7mm X 175mm 812258028268 P10.7-50N160 PA0902-50N160 Universal Femur 10.7mm X 160mm 00887517937278 P10.7-50P160 PA0902-50P160 Retrograde Femur 10 Ben d 10.7mm x 160 mm 812258028282 P10.7-50P175 PA0902-50P175 Retrograde Femur 10 Bend 10.7mm x 175mm 00887517937285 P10.7-50Q150 PA0902-50Q150 Antegrade Tibia 10 Bend 10.7mm X 150mm 812258028220 P10.7-50Q155 PA0902-50Q155 Antegrade Tibia 10 Bend 10.7mm X 155mm 812258026264 P10.7-50U190 PA0676-50U190 Universal Femur 10.7MM X 190MM 887517934819 P10.7-50V215 PA0411-50V215 Retrograde Femur 10deg, 10.7mm x 215mm 887517934826 P10.7-50V230 PA0411-50V230 Retrograde Femur 10deg, 10.7mm x 230mm 887517934833 P10.7-50X215 PA0411-50X215 Retrograde Femur Straigh t, 10.7mm x 215mm 887517934840 P10.7-50X230 PA0411-50X230 Retrograde Femur Straigh t, 10.7mm x 230mm 812258020071 P10.7-80A245 PA0411-80A245 Retrograde Femur 10deg, 10.7mm x 245mm 812258020088 P10.7-80A275 PA0411-80A275 Retrograde Femur 10deg, 10.7mm x 275mm 812258020095 P10.7-80A305 PA0411-80A305 Retrograde Femur 10deg, 10.7mm x 305mm 812258020101 P10.7-80A335 PA0411-80A335 Retrograde Femur 10deg, 10.7mm x 335mm 812258020118 P10.7-80A365 PA0411-80A365 Retrograde Femur 10deg, 10.7mm x 365mm 812258020255 P10.7-80B245 PA0411-80B245 Ante Femur Piriformis, 1 0.7mm x 245mm 812258020262 P10.7-80B275 PA0411-80B275 Ante Femur Piriformis, 1 0.7mm x 275mm 812258020279 P10.7-80B305 PA0411-80B305 Ante Femur Piriformis, 1 0.7mm x 305mm 812258020286 P10.7-80B335 PA0411-80B335 Ante Femur Piriformis, 1 0.7mm x 335mm 812258020293 P10.7-80B365 PA0411-80B365 Ante Femur Piriformis, 1 0.7mm x 365mm 812258020453 P10.7-80C245 PA0411-80C245 Antegrade Tibia, 10.7mm x 245mm 812258020460 P10.7-80C275 PA0411-80C275 Antegrade Tibia, 10.7mm x 275mm 812258020477 P10.7-80C305 PA0411-80C305 Antegrade Tibia, 10.7mm x 305mm 812258020484 P10.7-80C335 PA0411-80C335 Antegrade Tibia, 10.7mm x 335mm 812258020491 P10.7-80C365 PA0411-80C365 Antegrade Tibia, 10.7mm x 365mm 812258020644 P10.7-80D245 PA0411-80D245 Ante Femur (Troch), 10.7 mm x 245mm 812258020651 P10.7-80D275 PA0411-80D275 Ante Femur (Troch), 10.7 mm x 275mm 812258020668 P10.7-80D305 PA0411-80D305 Ante Femur (Troch), 10.7 mm x 305mm 812258020675 P10.7-80D335 PA0411-80D335 Ante Femur (Troch), 10.7 mm x 335mm 812258020682 P10.7-80D365 PA0411-80D365 Ante Femur (Troch), 10.7 mm x 365mm 812258020828 P10.7-80E245 PA0411-80E245 Retrograde Femur Straigh t, 10.7mm x 245mm 812258020835 P10.7-80E275 PA0411-80E275 Retrograde Femur Straigh t, 10.7mm x 275mm 812258020842 P10.7-80E305 PA0411-80E305 Retrograde Femur Straigh t, 10.7mm x 305mm 812258020859 P10.7-80E335 PA0411-80E335 Retrograde Femur Straigh t, 10.7mm x 335mm 812258020866 P10.7-80E365 PA0411-80E365 Retrograde Femur Straigh t, 10.7mm x 365mm 887517934857 P10.7-80V245 PA0411-80V245 Retrograde Femur 10deg, 10.7mm x 245mm 887517934864 P10.7-80V275 PA0411-80V275 Retrograde Femur 10deg, 10.7mm x 275mm 887517934871 P10.7-80V305 PA0411-80V305 Retrograde Femur 10deg, 10.7mm x 305mm 887517934888 P10.7-80V335 PA0411-80V335 Retrograde Femur 10deg, 10.7mm x 335mm 887517934895 P10.7-80V365 PA0411-80V365 Retrograde Femur 10deg, 10.7mm x 365mm 887517935502 P10.7-80X245 PA0411-80X245 Retrograde Femur Straigh t, 10.7mm x 245mm 887517935519 P10.7-80X275 PA0411-80X275 Retrograde Femur Straigh t, 10.7mm x 275mm 887517935526 P10.7-80X305 PA0411-80X305 Retrograde Femur Straigh t, 10.7mm x 305mm 887517935533 P10.7-80X335 PA0411-80X335 Retrograde Femur Straigh t, 10.7mm x 335mm 887517935540 P10.7-80X365 PA0411-80X365 Retrograde Femur Straigh t, 10.7mm x 365mm 812258026097 P12.5-30H170 PA0677-30H170 Retrograde Femur 10 Ben d 12.5MM X 170MM 812258026158 P12.5-30J160 PA0677-30J160 Antegrade Tibia 10 Bend 12.5MM X 160MM 812258026219 P12.5-30K170 PA0677-30K170 Antegrade Femur Troch 10 Bend 12.5MM X 170MM 812258026271 P12.5-30U170 PA0677-30U170 Universal Femur 12.5MM 1 70MM 812258020125 P12.5-50A215 PA0417-50A215 Retrograde Femur 10deg, 12.5mm x 215mm 812258020132 P12.5-50A230 PA0417-50A230 Retrograde Femur 10deg, 12.5mm x 230mm 812258020309 P12.5-50B215 PA0417-50B215 Ante Femur Piriformis, 1 2.5mm x 215mm 812258020316 P12.5-50B230 PA0417-50B230 Ante Femur Piriformis, 1 2.5mm x 230mm 812258020507 P12.5-50C195 PA0417-50C195 Antegrade Tibia, 12.5mm x 1...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

U.S.: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, WI, and WV. O.U.S.: Argentina, Australia, Austria, Belgium, Canada, Colombia, Chile, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Jordan, Luxemburg, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, UAE, United Kingdom.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Dec 8, 2021
Recall initiation date: Oct 29, 2021
Center classification date: Dec 1, 2021

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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