Recall Z-2056-2017 ยท LOD Bone Cement
Zimmer Biomet, Inc.
Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
| Date | Apr 25, 2017 (initiated Apr 13, 2017) |
| Status | Terminated |
| Reason | Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device. |
| Root cause | Under Investigation by firm |
| Action | On 4/13/2017 URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications were sent to the affected consignees via e-mail. 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. |
| Quantity | 4238 |
| Distribution | TX. Japan Mexico |
| FDA record | Open on fda.gov |