Smith & Nephew OXINIUM Femoral Head Recall: Packaging Size Mismatch
Smith & Nephew is recalling OXINIUM Femoral Head components due to packaging containing incorrect product sizes compared to labels. The mismatch affects 23 packages distributed internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of orthopedic implant components with documented size mismatch between packaging and contents. No illnesses or injuries reported, but the hazard is significant—incorrect femoral head size could result in improper surgical fit and serious complications.
Plain-English summary
Smith & Nephew Inc. is recalling OXINIUM Femoral Head components (REF 71343204 and REF 71343604) because the packaging contained femoral heads of incorrect sizes compared to what the labels indicated.
The affected batches (23FM03219 for REF 71343204 and 23FM04184 for REF 71343604, both expiring June 2033) were distributed to Australia, Germany, Japan, Portugal, and the United Kingdom.
If you have received any of these products, do not use them without verifying the actual component size matches your intended size. Contact Smith & Nephew for proper replacement or disposition.
The recalled product
- 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
- Manufacturer
- Smith & Nephew Inc
- Hazard
- size-mismatch
- labeling-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- REF 71343204 - Batch #23FM03219
- Exp. June 2033
- REF 71343604 - Batch 23FM04184
- Exp. June 2033.
Distribution
Distribution scope not specified by the agency.
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