Device product
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phase 3 Femoral Drill Guide Small
Z-1736-2019
Product summary
- Event
- Event 82818
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41 units
- Official record key
device-enforcement:Z-1736-2019
Official wording
Reason: Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Code information: Lot Numbers: ZB160201 ZB160401 ZB161101 ZB170401 ZB170601 ZB170801 ZB170901
Distribution pattern: CA, IN, LA, NM, NY, TX, WI Foreign: CANADA, AUSTRALIA, JAPAN, NETHERLANDS
Derived failure modes
-
Unknown
Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.