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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: LEGION Knee Implant Recalled for Packaging and Labeling Error

Agency Publication Date: September 20, 2023
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Summary

Smith & Nephew Inc. is recalling 8 units of the LEGION OXINUM Posterior Stabilized Knee Implant, specifically the Size 5N Left Narrow model. A complaint revealed that a package labeled as a Size 5N implant actually contained a smaller Size 4N implant inside. This labeling error was discovered after a report of an incorrect component being found in the sterile packaging, which could lead to surgical delays or the use of an improperly sized device.

Risk

If an incorrectly sized implant is used during surgery due to a labeling error, it can lead to poor joint fit, increased wear on the device, and potential revision surgery. The mismatch between the label and the physical component can also cause significant surgical delays while a correct replacement is located.

What You Should Do

  1. Identify if you have the affected medical device by checking the product label for 'LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW' with Reference Number 71421265.
  2. Verify the specific identification codes on the packaging: look for UDI/DI 00885556234006 and Lot Number 23EM09878.
  3. If you are a healthcare provider or facility, immediately stop using and quarantine any units matching this lot number to prevent implantation.
  4. Contact Smith & Nephew Inc. directly at their Memphis headquarters for instructions on returning the mislabeled products and obtaining a replacement.
  5. Patients who have recently undergone knee replacement surgery with a LEGION system and have concerns should contact their orthopedic surgeon or healthcare provider for further guidance.
  6. For additional questions regarding this recall, contact the FDA 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 LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW
Model / REF:
REF 71421265
UPC Codes:
00885556234006
Lot Numbers:
23EM09878

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92976
Status: Active
Manufacturer: Smith & Nephew Inc
Sold By: hospitals; surgical centers
Manufactured In: United States
Units Affected: 8 units
Distributed To: Ohio, Connecticut, Texas, North Carolina, California, Nebraska, Nevada

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.