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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 LEGION OXINIUM Knee Implants Recalled for Incorrect Labeling

Agency Publication Date: October 30, 2024
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Summary

Smith & Nephew is recalling five LEGION OXINIUM Constrained Femoral Component knee implants because of a labeling error where the size listed on the outside of the package does not match the implant inside. Specifically, a package labeled as Size 4 contained a Size 3 implant. This error was discovered after a complaint was received, though no injuries have been reported. The recall affects units sold to surgical facilities in Texas, as well as several international locations.

Risk

If an incorrectly sized implant is used during surgery, it may result in a poor fit or surgical delays while a correctly sized replacement is located. If the mismatch is not identified before implantation, the patient may require additional revision surgery to correct the issue.

What You Should Do

  1. This recall affects Smith & Nephew LEGION OXINIUM Constrained Nonporous Femoral Components (Size 3 Left and Size 4 Left) with reference numbers 71421163 and 71421164.
  2. Check the batch number and Unique Device Identifier (UDI) on the product packaging. The affected batch numbers are 23LM00479 (Size 3) and 23LM03388 (Size 4).
  3. Stop using the recalled device. Contact Smith & Nephew or your distributor to arrange for the return, replacement, or correction of the affected units.
  4. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: LEGION OXINIUM Constrained Nonporous Femoral Component, Size 3 Left
Variants: Size 3 Left, Nonporous, Cemented
Model / REF:
71421163
Lot Numbers:
23LM00479
UDI:
03596010543820

Recall number Z-0277-2025; Quantity: 3 units

Product: LEGION OXINIUM Constrained Nonporous Femoral Component, Size 4 Left
Variants: Size 4 Left, Nonporous, Cemented
Model / REF:
71421164
Lot Numbers:
23LM03388
UDI:
03596010543837

Recall number Z-0278-2025; Quantity: 2 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95493
Status: Active
Manufacturer: Smith & Nephew Inc
Sold By: hospitals; surgical centers; orthopedic clinics
Manufactured In: United States
Units Affected: 2 products (3 units; 2 units)
Distributed To: Texas

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.