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
- Company
- Medacta Usa Inc
- Recall Initiated
- October 24, 2017
- Posted
- December 20, 2017
- Terminated
- June 20, 2018
- Recall Number
- Z-0266-2018
- Quantity
- 12,768 units
- Firm Location
- Memphis, TN
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
nationwide
Lot / Code Info
all serial numbers
Root Cause
Device Design
Action Taken
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.