medical Class II Updated 2018-05-23

Zimmer Biomet, Inc. recalls Persona Cemented Tibial SZ PLT Size H Right, Item Number 425

Recalled Product

Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot 63688256, UDI (01)00889024247581(10)63688256; Lot 63576041, UDI (01)00889024247581(10)63576041; Lot 63531871, UDI (01)00889024247581(10)63531871
View official government recall

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