FDAClass IIJune 5, 2024

smith&nephew OXINIUM Femoral Head 12/14 Taper recall

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

Why was smith&nephew OXINIUM Femoral Head 12/14 Taper recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

REF 71343204 - Batch #23FM03219, Exp. June 2033; REF 71343604 - Batch 23FM04184, Exp. June 2033.

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
Recalling firm
Smith & Nephew Inc
Quantity
23 packages
Distribution
International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.
Recall date
June 5, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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