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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Smith & Nephew Inc: OXINIUM Femoral Heads Recalled for Incorrect Size Labeling

Agency Publication Date: May 24, 2024
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Summary

Smith & Nephew Inc. is recalling 23 units of OXINIUM Femoral Heads used in hip replacement surgeries because the packaging may contain a different size femoral head than what is listed on the label. This recall affects the 32 MM OD +4 and 36 MM M / +4 models distributed to several international locations. Consumers who have undergone a recent hip procedure involving these components should consult their surgeon to ensure the correct device was used. If you have an unused package, contact the manufacturer immediately for instructions.

Risk

The use of an incorrectly sized femoral head during surgery can lead to improper joint fit, potentially causing pain, limited mobility, or requiring a follow-up revision surgery to correct the error.

What You Should Do

  1. Check your medical records or contact your orthopedic surgeon if you have recently undergone hip replacement surgery to determine if the Smith & Nephew OXINIUM Femoral Head was used.
  2. Verify the model and batch numbers if you have access to the product packaging: look for REF 71343204 (Batch #23FM03219, Expiration June 2033) or REF 71343604 (Batch 23FM04184, Expiration June 2033).
  3. If you are a healthcare provider or distributor holding any of these specific units, immediately quarantine the affected stock and do not use the products in surgery.
  4. Contact your healthcare provider or Smith & Nephew Inc. at 1-888-463-6332 for further instructions regarding the return or exchange of affected units.
  5. For additional information, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: smith&nephew OXINIUM Femoral Head 12/14 Taper, 32 MM OD +4
Model / REF:
REF 71343204
Z-1901-2024
Lot Numbers:
23FM03219 (Exp. June 2033)
Date Ranges: June 2033
Product: smith&nephew OXINIUM Femoral Head 12/14 Taper, 36 MM M / +4
Model / REF:
REF 71343604
Z-1901-2024
Lot Numbers:
23FM04184 (Exp. June 2033)
Date Ranges: June 2033

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94555
Status: Active
Manufacturer: Smith & Nephew Inc
Sold By: Specialty medical distributors; Hospitals
Manufactured In: United States
Units Affected: 23 packages
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.