Z-0266-2018 Class II Terminated
FDA device recall Z-0266-2018 was initiated by Medacta Usa Inc on October 24, 2017 and is designated Class II. Reason for recall: 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 i… The recall status is terminated (terminated June 20, 2018). Affected quantity: 12,768 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 27, 2017
- Initiation Date
- October 24, 2017
- Termination Date
- June 20, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,768 units
Product Description
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
Reason for Recall
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.
Distribution Pattern
nationwide
Code Information
all serial numbers