FDAFDA · Food and drugs·Recall number Z-0266-2018
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
Published December 27, 2017 · Recall initiated: October 24, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Medacta Usa Inc
- Distributor
- nationwide
- Lot
- all serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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