Home / Recalls / Medical Devices
Medacta Usa Inc recalls The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number
Recalled December 27, 2017 · FDA recall Z-0266-2018 · Medacta Usa
Hazard
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. · FDA Class II
Units
12,768 units
Sold at
nationwide
Description
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.
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
Manufacturer(s)
Medacta Usa Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →