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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

Zimmer Biomet, Inc.: Label on the outer carton or the patient labels does not match label on the inner sterile packaging

Agency Publication Date: November 21, 2018
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Affected Products

Product: Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126

Lot Number: J6255863 UDI: (01)00880304270794(17)280411(10)J6265594

Lot Numbers:
Number
Product: Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108

Lot Number: J6265594 UDI: (01)00880304270893(17)280411(10)J6255863

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81472
Status: Resolved
Manufacturer: Zimmer Biomet, Inc.
Manufactured In: United States
Units Affected: 2 products (8 units)

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.

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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 · 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.