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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.: Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.

Agency Publication Date: March 13, 2018
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Affected Products

Product: Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty

PN: 113633, LN: 421700, UDI# - (01) 00880304462632 (17) 271014 (10) 421700

Product: Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty

PN: 113617, LN: 552850, UDI# - (01) 00880304554184 (17) 271014 (10) 552850

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79385
Status: Resolved
Manufacturer: Zimmer Biomet, Inc.
Manufactured In: United States
Units Affected: 2 products (12)

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.