Device product
Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
Z-0317-2017
Product summary
- Event
- Event 75371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 703
- Official record key
device-enforcement:Z-0317-2017
Official wording
Reason: 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
Code information: Item Number 00-5927-040-00 Serial Number All
Distribution pattern: Nationwide. CANADA HONG KONG KOREA SINGAPORE CHINA VENEZUELA AUSTRALIA JAPAN NETHERLANDS GERMANY INDIA TAIWAN
Derived failure modes
-
Unknown
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