Reported Dec 27, 2017 · Terminated
The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number…
Medacta USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medacta Usa Inc · 3973 Delp St · Memphis, TN · 38118-6110
Is this the product you have?
- The GMK knee systemdesigned for cemented use in total knee arthroplasty. Sphere and
- Primary Inserts with part number ranges
02.12.0110FL - 02.12.0620FL02.12.0110FR - 02.12.0620FR02.07.0110PSF - 02.07.0620PSF
- Lot codes and dates
- all serial numbers
- Amount recalled
- 12,768 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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