Device product
smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
Z-1901-2024
Product summary
- Event
- Event 94555
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23 packages
- Official record key
device-enforcement:Z-1901-2024
Official wording
Reason: Packaging contained the incorrect size of femoral head from what was displayed on the label.
Code information: REF 71343204 - Batch #23FM03219, Exp. June 2033; REF 71343604 - Batch 23FM04184, Exp. June 2033.
Distribution pattern: International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.
Derived failure modes
-
Unknown
Packaging contained the incorrect size of femoral head from what was displayed on the label.