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Recall Observatory FDA recall evidence

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

April 24, 2024

Class II

Product summary

Firm
Smith & Nephew Inc
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

    reason.no_named_rule · v1.0.0

    Packaging contained the incorrect size of femoral head from what was displayed on the label.