Zimmer Biomet, Inc. recalls Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece

Recall date

September 28, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0317-2017

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

Nationwide. CANADA HONG KONG KOREA SINGAPORE CHINA VENEZUELA AUSTRALIA JAPAN NETHERLANDS GERMANY INDIA TAIWAN

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece