Recall Z-0594-2020 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Biomet, Inc.
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
| Date | Oct 25, 2019 |
| Status | Terminated |
| Reason | Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam |
| Root cause | Error in labeling |
| Action | Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL letter via FedEx and email on 10/25/19. The letter identifies the reason for recall, health risk and action to take: Review this notification and ensure that affected personnel are aware of the contents. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. Retai |
| Quantity | 26 units |
| Distribution | Distribution to US states of CA, FL, IN, MN, MO, NY, and UT, Australia, and New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.