FDA-Device2016-11-02Class II

Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece

Zimmer Biomet, Inc.
Hazard

Complaints have been reported that the handpiece is inoperable. The investigation found that the complaints were related to the lack of preventative maintenance contrary to what is recommended in the instructions for use included with the handpiece. An inoperable device may lead to a delay in surgery

Sold states
Nationwide. CANADA HONG KONG KOREA SINGAPORE CHINA VENEZUELA AUSTRALIA JAPAN NETHERLANDS GERMANY INDIA TAIWAN
Affected count
703
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0317-2017

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