Recall Z-0266-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Medacta Usa Inc
The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF
| Date | Dec 20, 2017 (initiated Oct 24, 2017) |
| Status | Terminated |
| Reason | Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in our surgical techniques. |
| Root cause | Device Design |
| Action | All surgeon customers shall be notified via email by October 24, 2017 of the reminder to follow the surgical technique. To ensure that surgeons receive the notification, we will send the letter via email so that we can track and ensure the message was received. If the email is returned, we would then send a personalized letter directly to the surgeon. A copy of this notification is included with the submission of this report. |
| Quantity | 12,768 units |
| Distribution | nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090988 | GMK TOTAL KNEE SYSTEM Medacta International S.A., Jul 10, 2009 |