--- title: "Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straigh... — FDA record Z-0500-2025 | Is It on Recall" description: "Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices." url: https://isitonrecall.com/recall/fda-device-z-0500-2025-precice-max-ref-pm10-0-80b265-precice-max-antegrade-femur-piriformis-straight-10-0mm-x-265mm-pm10-0/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE M... — FDA record Z-0500-2025 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 Sep 30, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. 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/). ## What the record says - **Product**: Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm PM10.0-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 335mm PM10.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 365mm PM10.0-80TJ265 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 265mm PM10.0-80TJ280 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 280mm PM10.0-80TJ305 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 305mm PM11.5-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 265mm PM11.5-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 280mm PM11.5-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 305mm PM11.5-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 335mm PM11.5-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 365mm PM11.5-80TJ265 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 265mm PM11.5-80TJ280 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 280mm PM11.5-80TJ305 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 305mm PM13.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 280mm PM13.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 305mm PM13.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 365mm The Precice Max Nail is intended to stabilize fractures, nonunions, and malunions of the femur, tibia, and humerus. In addition, the Precice Nail is intended to provide magnetically controlled lengthening of long bones and/or transporting of bone segments in the femur, tibia, and humerus. - **Reason**: Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices. - **Classification**: Class II - **Recalling firm**: NuVasive Specialized Orthopedics, Inc. - **Quantity**: 164 devices - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0500-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0500-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Part Number: PM10.0-80B265 UDI codes: (01)00195377150929(11)240223(17)290131(10)4021504AAA (01)00195377150929(11)240301(17)290228(10)4022214AAA Lot Numbers: 4021504AAA 4022214AAA Part Number: PM10.0-80B280 UDI codes: (01)00195377151032(11)240222(17)290131(10)4021505AAA (01)00195377151032(11)240220(17)290131(10)4021903AAA Lot Numbers: 4021505AAA 4021903AAA Part Number: PM10.0-80B305 UDI Codes: (01)00195377151148(11)240214(17)290131(10)4021217AAA (01)00195377151148(11)240220(17)290131(10)4021901AAA (01)00195377151148(11)240304(17)290228(10)4022131AAA Lot Numbers: 4021217AAA 4021901AAA 4022131AAA PM10.0-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 335mm 4021218AAA (01)00195377151254(11)240215(17)290131(10)4021218AAA 4021910AAA (01)00195377151254(11)240221(17)290131(10)4021910AAA 4022301AAA (01)00195377151254(11)240304(17)290228(10)4022301AAA 4022625AAA (01)00195377151254(11)240301(17)290228(10)4022625AAA PM10.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 365mm 4022135AAA (01)00195377151360(11)240304(17)290228(10)4022135AAA 4022136AAA (01)00195377151360(11)240223(17)290131(10)4022136AAA PM10.0-80TJ265 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 265mm 4021307AAA (01)00195377150998(11)240219(17)290131(10)4021307AAA 4021926AAA (01)00195377150998(11)240221(17)290131(10)4021926AAA PM10.0-80TJ280 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 280mm 4021314AAA (01)00195377151100(11)240215(17)290131(10)4021314AAA 4021602AAA (01)00195377151100(11)240223(17)290131(10)4021602AAA 4022005AAA (01)00195377151100(11)240222(17)290131(10)4022005AAA PM10.0-80TJ305 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 305mm 4021401AAA (01)00195377151216(11)240229(17)290131(10)4021401AAA PM11.5-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 265mm 4021524AAA (01)00195377151698(11)240219(17)290131(10)4021524AAA PM11.5-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 280mm 4021502AAA (01)00195377151803(11)240216(17)290131(10)4021502AAA 4021503AAA (01)00195377151803(11)240216(17)290131(10)4021503AAA PM11.5-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 305mm 4021203AAA (01)00195377151919(11)240215(17)290131(10)4021203AAA 4021921AAA (01)00195377151919(11)240227(17)290131(10)4021921AAA 4022010AAA (01)00195377151919(11)240301(17)290228(10)4022010AAA PM11.5-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 335mm 4021205AAA (01)00195377152022(11)240216(17)290131(10)4021205AAA 4021530AAA (01)00195377152022(11)240219(17)290131(10)4021530AAA 4022011AAA (01)00195377152022(11)240228(17)290131(10)4022011AAA PM11.5-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 365mm 4021902AAA (01)00195377152138(11)240222(17)290131(10)4021902AAA PM11.5-80TJ265 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 265mm 4021404AAA (01)00195377151766(11)240221(17)290131(10)4021404AAA PM11.5-80TJ280 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 280mm 4021501AAA (01)00195377151872(11)240219(17)290131(10)4021501AAA 4022626AAA (01)00195377151872(11)240304(17)290228(10)4022626AAA PM11.5-80TJ305 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 305mm 4021407AAA (01)00195377151988(11)240216(17)290131(10)4021407AAA PM13.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 280mm 4021525AAA (01)00195377152572(11)240220(17)290131(10)4021525AAA 4022009AAA (01)00195377152572(11)240221(17)290131(10)4022009AAA PM13.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 305mm 4022623AAA (01)00195377152688(11)240301(17)290228(10)4022623AAA PM13.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 365mm 4022001AAA (01)00195377152909(11)240221(17)290131(10)4022001AAA | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution U.S distribution to states of: FL and NV. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Florida](https://isitonrecall.com/state/florida/) - [Nevada](https://isitonrecall.com/state/nevada/) ## Dates in the source - **Report date**: Nov 27, 2024 - **Recall initiation date**: Sep 30, 2024 - **Center classification date**: Nov 21, 2024 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 to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0500-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [NuVasive Specialized Orthopedics, Inc. records](https://isitonrecall.com/brand/nuvasive-specialized-orthopedics-inc/)