Recall Z-2068-2017 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Zimmer Biomet, Inc.
Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis
| Date | Apr 25, 2017 (initiated Mar 22, 2017) |
| Status | Terminated |
| Reason | pegs shearing post-operatively |
| Root cause | Under Investigation by firm |
| Action | On 3/22/2017 URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees 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. Distributors, Sales Representatives, and Distributor Operation Managers Your Responsibilities 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification |
| Quantity | 8154 |
| Distribution | US Nationwide.distribution and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083782 | REGENEREX PATELLA COMPONENTS Biomet Manufacturing Corp, Apr 3, 2009 |