Recall Z-0317-2017— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2016-09-28, terminated 2020-04-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece. 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.
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-28
- Terminated
- 2020-04-16
- Firm location
- Warsaw, IN, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.