FDA Device recall Z-0500-2025
Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Pir…
- FDA Device
- Class II
- ongoing
- Published 2024-11-27
On 2024-11-27 the FDA classified a Class II recall of Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Pir… by Nuvasive Specialized Orthopedics, citing due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0500-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-30 |
| Published | 2024-11-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Nuvasive Specialized Orthopedics |
| Distribution | FL, NV |
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.
Identifiers
| code_info | Part Number: PM10.0-80B265 UDI codes: (01)00195377150929(11)240223(17)290131(10)4021504AAA (01)00195377150929(11)240301…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0500-2025%22
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