Device product
Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
Z-0084-2021
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 86424
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units OUS
- Official record key
device-enforcement:Z-0084-2021
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: 894660A 894660B 894670B 894700B
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