Device product
Biomet Regenerex Primary Taper Cap Item Number 141269
Z-0081-2021
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 86424
- Status
- Terminated
- Classification
- Class II
- Quantity
- US: 62 units; OUS: 176 units
- Official record key
device-enforcement:Z-0081-2021
Official wording
Reason: Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Code information: Lot Numbers: 015800 324440 685300 023900 324440R 696280 058930 389060 821980 200720 418430 890320 313260 646040 997610
Distribution pattern: Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM
Derived failure modes
-
Unknown
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized