Medacta Usa Inc Recall: The GMK knee system: designed for cemented use in total knee arthr
Medacta Usa Inc Recall: The GMK knee system: designed for cemented use in total knee arthr is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Medacta Usa Inc; Product: The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ra
| Recalling firm | Medacta Usa Inc |
|---|---|
| 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 |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | nationwide |
| Recall initiated | 20171024 |
| Recall number | Z-0266-2018 |
| Category | device |
| State | TN |
| Country | United States |
$29/mo
Try RecallGuard →