Recall Z-2661-2017 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Medacta Usa Inc
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
| Date | Jun 12, 2017 (initiated May 19, 2017) |
| Status | Terminated |
| Reason | One lot of product does not include a screw for attachment to the tibial base plate. |
| Root cause | Nonconforming Material/Component |
| Action | On 5/19/17 all distributors with recalled product were immediately notified of the recall by email. On 5/23/17, all distributors were further notified of the recall via phone. On 5/30/17, a third notification was completed via phone. |
| Quantity | 4 units |
| Distribution | CA, AZ, NC, Israel, France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130299 | GMK HINGE Medacta International, Aug 15, 2013 |