Recall Z-0273-2023 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Corin Ltd
Unity Total Knee System. Used for knee prosthesis in total knee replacement
| Date | Nov 21, 2022 (initiated Oct 31, 2022) |
| Status | Terminated |
| Reason | The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging. |
| Root cause | Under Investigation by firm |
| Action | Corin Group notified consignees on 10/31/2022 via letter titled "URGENT MEDICAL DEVICE RECALL." The letter instructed consignees to examine inventory, quarantine affected product, arrange for its return, and notify all facilities/personnel if devices were further distributed. Consignees were also asked to complete and return the acknowledgement form by e-mail to vigilance@coringroup.com. For all questions on this notice, please contact me at +1 772-321-2478 or by e-mail to vigilance@coringroup.com. |
| Quantity | 4 devices |
| Distribution | Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113060 | UNITY TOATAL KNEE SYSTEM Corin USA, Sep 10, 2012 |