Device product
Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 00877504004
Z-0336-2020
Product summary
- Event
- Event 83962
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,459,583 total devices
- Official record key
device-enforcement:Z-0336-2020
Official wording
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Code information: All products manufactured prior to January 2014.
Distribution pattern: Distributed nationwide.
Derived failure modes
-
Unknown
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).