--- title: "Synthes (USA) Products LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Synthes (USA) Products LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/synthes-usa-products-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Synthes (USA) Products LLC recall records **24** reported ongoing 24 records in this archive. Latest source date Feb 25, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Feb 25, 2026 FDA device enforcement ### [2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.](https://isitonrecall.com/recall/fda-device-z-1702-2026-2-4-volt-tap-locking-screw-tap-to-90mm-part-number-03-424-124-us/) A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. Class II Reported ongoing Distribution: US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI. [Official source for 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1702-2026%22) Feb 25, 2026 FDA device enforcement ### [2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.](https://isitonrecall.com/recall/fda-device-z-1703-2026-2-4-volt-tm-tap-cortex-screw-to-90mm-part-number-03-424-126-us/) A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. Class II Reported ongoing Distribution: US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI. [Official source for 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1703-2026%22) Sep 26, 2025 FDA device enforcement ### [LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Adv...](https://isitonrecall.com/recall/fda-device-z-0228-2026-low-prof-lckng-screw-f-im-nail-5-0mm-l-46mm-xl25-ster-product-code-04-045-346ts-used-in-rfn-advanced/) Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and the country of Canada. [Official source for LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0228-2026%22) Sep 26, 2025 FDA device enforcement ### [LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Adv...](https://isitonrecall.com/recall/fda-device-z-0229-2026-low-prof-lckng-screw-f-im-nail-5-0mm-l-42mm-xl25-ster-product-code-04-045-342ts-used-in-rfn-advanced/) Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and the country of Canada. [Official source for LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0229-2026%22) Apr 25, 2024 FDA device enforcement ### [STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010](https://isitonrecall.com/recall/fda-device-z-1916-2024-stardrive-scrwdrvr-shft-t4-50mm-self-retaining-hxc-intended-for-tightening-loosening-or-removing-of/) Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Canada. [Official source for STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removin...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1916-2024%22) Jan 24, 2024 FDA device enforcement ### [13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instabil...](https://isitonrecall.com/recall/fda-device-z-1234-2024-13-mm-titanium-hindfoot-arthrodesis-cannulated-nails-ex-sterile-intended-to-facilitate-tibiotalocalc/) Products not sterilized, sterility cannot be confirmed Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Irel... [Official source for 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotal...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1234-2024%22) Jan 24, 2024 FDA device enforcement ### [1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S](https://isitonrecall.com/recall/fda-device-z-1235-2024-1-5mm-drill-bit-qc-85mm-sterile-surgical-orthopedic-pneumatic-powered-accessory-attachment-part-numb/) Products not sterilized, sterility cannot be confirmed Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Irel... [Official source for 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Pa...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1235-2024%22) Jan 24, 2024 FDA device enforcement ### [2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S](https://isitonrecall.com/recall/fda-device-z-1236-2024-2-5mm-drill-bit-qc-gold-110mm-sterile-surgical-orthopedic-pneumatic-powered-accessory-attachment-pro/) Products not sterilized, sterility cannot be confirmed Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Irel... [Official source for 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachm...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1236-2024%22) Jan 24, 2024 FDA device enforcement ### [RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effecti...](https://isitonrecall.com/recall/fda-device-z-1237-2024-ria-tube-assembly-minimum-520-mm-length-sterile-intended-for-use-in-adults-and-adolescents-12-21-yea/) Products not sterilized, sterility cannot be confirmed Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Irel... [Official source for RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1237-2024%22) Jan 24, 2024 FDA device enforcement ### [RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lowe...](https://isitonrecall.com/recall/fda-device-z-1238-2024-rapidsorb-ips-battery-pack-sterile-intended-for-use-in-non-load-bearing-fracture-repair-and-reconstr/) Products not sterilized, sterility cannot be confirmed Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Irel... [Official source for RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reco...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1238-2024%22) Jan 24, 2024 FDA device enforcement ### [TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S](https://isitonrecall.com/recall/fda-device-z-1239-2024-tfna-femoral-nail-9mm-right-130-l-235mm-intended-for-temporary-fixation-and-stabilization-of-proxima/) Products not sterilized, sterility cannot be confirmed Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Irel... [Official source for TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1239-2024%22) Jan 24, 2024 FDA device enforcement ### [TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S](https://isitonrecall.com/recall/fda-device-z-1240-2024-tfna-femoral-nail-11mm-right-130-l-235mm-intended-for-temporary-fixation-and-stabilization-of-proxim/) Products not sterilized, sterility cannot be confirmed Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Irel... [Official source for TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1240-2024%22) Jan 24, 2024 FDA device enforcement ### [VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S](https://isitonrecall.com/recall/fda-device-z-1241-2024-va-lcp-clavicle-plate-2-7-shaft-cs1-right-intended-for-fixation-of-clavicle-bone-fragments-part-numb/) Products not sterilized, sterility cannot be confirmed Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Irel... [Official source for VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Pa...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1241-2024%22) Jan 24, 2024 FDA device enforcement ### [Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S](https://isitonrecall.com/recall/fda-device-z-1242-2024-opal-intervertebral-cage-10x32mm-h-11mm-revolvable-indicated-for-degenerative-spine-disease-part-num/) Products not sterilized, sterility cannot be confirmed Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Irel... [Official source for Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease P...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1242-2024%22) Feb 1, 2023 FDA device enforcement ### [TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S](https://isitonrecall.com/recall/fda-device-z-1246-2023-tfn-advanced-femoral-nail-12mm-125-deg-ti-cann-tfna-200mm-sterile-intended-for-temporary-fixation-an/) TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan. [Official source for TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixatio...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1246-2023%22) Feb 1, 2023 FDA device enforcement ### [TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S](https://isitonrecall.com/recall/fda-device-z-1247-2023-tfn-advanced-femoral-nail-12mm-125-deg-ti-cann-tfna-170mm-sterile-intended-for-temporary-fixation-an/) TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan. [Official source for TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixat...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1247-2023%22) Feb 1, 2023 FDA device enforcement ### [TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S](https://isitonrecall.com/recall/fda-device-z-1248-2023-tfn-advanced-femoral-nail-12mm-130-deg-ti-cann-tfna-170mm-sterile-intended-for-temporary-fixation-an/) TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan. [Official source for TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixatio...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1248-2023%22) Sep 27, 2022 FDA device enforcement ### [SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and managem...](https://isitonrecall.com/recall/fda-device-z-0098-2023-speedshift20x20x20-offset-10mm-implant-drill-kit-product-no-se-2020-10-used-with-depuy-synthes-speed/) The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone da... Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0098-2023%22) Sep 27, 2022 FDA device enforcement ### [SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512](https://isitonrecall.com/recall/fda-device-z-0099-2023-speed-15x12x12mm-continuous-compression-implant-product-no-se-1512/) The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone da... Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0099-2023%22) Sep 27, 2022 FDA device enforcement ### [SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910](https://isitonrecall.com/recall/fda-device-z-0100-2023-speed-9x10x10mm-continuous-compression-implant-product-no-se-0910/) The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone da... Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0100-2023%22) ## Reasons in these listed records - A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. - Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. - Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay - Products not sterilized, sterility cannot be confirmed These examples come from this result page and are not a ranking of every recall reason. ## Checking Synthes (USA) Products LLC ### Is there a recall on synthes (usa) products llc right now? This archive contains 24 records, including 24 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Synthes (USA) Products LLC](https://isitonrecall.com/check/?q=Synthes%20%28USA%29%20Products%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)