Recall Z-1318-2016 ยท KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Biomet, Inc.
All instrumentation associated with the Prelude PF Resurfacing Knee System.
| Date | Apr 4, 2016 (initiated Mar 9, 2016) |
| Status | Terminated |
| Reason | Inadequate design control. |
| Root cause | Device Design |
| Action | Zimmer Biomet sent an "Urgent Medical Device Recall Notice" dated March 9, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The following actions are REQUIRED: 1. Immediately locate and remove the identified device(s) listed below from circulation. 2. Carefully follow the instructions on the enclosed Response Form. 3.Email a copy of the response form to CPW ARFieldAction@zimmerbiomet.com prior to return of product. 4. Use priority carrier for your shipment. Please confirm receipt of this notice by sending back |
| Quantity | 576 |
| Distribution | US Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX. |
| FDA record | Open on fda.gov |