Device product
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
Z-0266-2018
Product summary
- Firm
- Medacta Usa Inc
- Event
- Event 78401
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,768 units
- Official record key
device-enforcement:Z-0266-2018
Official wording
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.
Code information: all serial numbers
Distribution pattern: nationwide
Derived failure modes
-
Unknown
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.