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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.: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.

Agency Publication Date: May 11, 2018
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Affected Products

Product: Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.

Lot 63535352, UDI (01)00889024246935(10)63607357; Lot 63535352, UDI (01)00889024246935(10)63535352

Lot Numbers:
63535352
63535352
Product: Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.

Lot 63683139, UDI (01)00889024246942(10)63683139; Lot 63613121, UDI (01)00889024246942(10)63613121

Lot Numbers:
63683139
63613121
Product: Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.

Lot 63693589, UDI (01)00889024247574(10)63693589; Lot 63649575, UDI (01)00889024247574(10)63649575; Lot 63576035, UDI (01)00889024247574(10)63576035; Lot 63531869, UDI (01)00889024247574(10)63531869

Lot Numbers:
63693589
63649575
63576035
63531869
Product: Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.

Lot 63688256, UDI (01)00889024247581(10)63688256; Lot 63576041, UDI (01)00889024247581(10)63576041; Lot 63531871, UDI (01)00889024247581(10)63531871

Lot Numbers:
63688256
63576041
63531871

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79991
Status: Resolved
Manufacturer: Zimmer Biomet, Inc.
Manufactured In: United States
Units Affected: 4 products (842 products in total)

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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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 · 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.