FDAClass IINovember 2, 2016

Zimmer¿ Gender Solutions" Patellofemoral Joint recall

Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece

Why was Zimmer¿ Gender Solutions" Patellofemoral Joint 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Item Number 00-5927-040-00 Serial Number All

Product
Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
Recalling firm
Zimmer Biomet, Inc.
Quantity
703
Distribution
Nationwide. CANADA HONG KONG KOREA SINGAPORE CHINA VENEZUELA AUSTRALIA JAPAN NETHERLANDS GERMANY INDIA TAIWAN
Recall date
November 2, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls