Z-0317-2017 Class II Terminated
FDA device recall Z-0317-2017 was initiated by Zimmer Biomet, Inc. on Sep 28, 2016 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Apr 16, 2020). Affected quantity: 703.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 2, 2016
- Initiation Date
- Sep 28, 2016
- Termination Date
- Apr 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 703
Product Description
Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
Reason for Recall
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
Distribution Pattern
Nationwide. CANADA HONG KONG KOREA SINGAPORE CHINA VENEZUELA AUSTRALIA JAPAN NETHERLANDS GERMANY INDIA TAIWAN
Code Information
Item Number 00-5927-040-00 Serial Number All
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0317-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026