FDAFDA · Food and drugs·Recall number Z-2661-2017
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
Published July 12, 2017 · Recall initiated: May 19, 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
One lot of product does not include a screw for attachment to the tibial base plate.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Medacta Usa Inc
- Distributor
- CA, AZ, NC, Israel, France
- Lot
- Lot # 163646
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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