The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number r
FDA device recall Z-0266-2018 · posted 2017-12-20 · Terminated
Recall details
- Recalling firm
- Medacta Usa Inc
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 12,768 units
- Distribution
- nationwide
- Date initiated
- 2017-10-24
- Date posted
- 2017-12-20
- Date terminated
- 2018-06-20
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GMK TOTAL KNEE SYSTEM (K090988) | Medacta International S.A. | 2009-07-10 |