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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.: The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.

Agency Publication Date: September 14, 2018
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Affected Products

Product: Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612

Lot Number 611330, UDI (1)00880304008526(17)221010(10)611330

Lot Numbers:
Number
Product: Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629

Lot Number 625450, UDI (1)00880304421066(17)221019(10)625450

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80843
Status: Resolved
Manufacturer: Zimmer Biomet, Inc.
Manufactured In: United States
Units Affected: 2 products (52)

Were You Affected by This Recall?

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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.