Recall Z-0317-2017 ยท HAB Saw, Powered, And Accessories
Zimmer Biomet, Inc.
Zimmer Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
| Date | Sep 28, 2016 |
| Status | Terminated |
| 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 |
| Root cause | Labeling design |
| Action | On 9/28/2016, URGENT MEDICAL DEVICE FIELD REMOVAL notifications were sent to the affected distributors and Risk Managers / Surgeons via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Risk Managers and Surgeons Risk Manager Responsibilities: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with quarantining all affected product. 3. Your Zimmer Biomet sal |
| Quantity | 703 |
| Distribution | Nationwide. CANADA HONG KONG KOREA SINGAPORE CHINA VENEZUELA AUSTRALIA JAPAN NETHERLANDS GERMANY INDIA TAIWAN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.