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Zimmer Biomet, Inc. recalls Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
Recalled November 2, 2016 · FDA recall Z-0317-2017 · Zimmer Biomet
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 · FDA Class II
Units
703
Sold at
Nationwide. CANADA HONG KONG KOREA SINGAPORE CHINA VENEZUELA AUSTRALIA JAPAN NETHERLANDS GERMANY INDIA TAIWAN
Description
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
Product
Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →