Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The GMK knee system: designed for cemented use in total Recalled by Medacta Usa Inc Due to Medacta has observed a worldwide occurrence rate of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medacta Usa Inc directly.
Affected Products
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
Quantity: 12,768 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medacta Usa Inc
Medacta Usa Inc has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report