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
Reported: December 27, 2017 Initiated: October 24, 2017 #Z-0266-2018
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.
Details
- Recalling Firm
- Medacta Usa Inc
- Units Affected
- 12,768 units
- Distribution
- nationwide
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Medacta Usa Inc. Units affected: 12,768 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 27, 2017. Severity: Moderate. Recall number: Z-0266-2018.
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