Reported Nov 25, 2015 · Terminated
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Medacta USA
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 · 1556 W Carroll Ave · Chicago, IL · 60607-1012
Is this the product you have?
- GMK Hinge knee prosthesis
- Model Number02.09.TA410; Orthopedics and Orthopedic Surgery
- Lot codes and dates
- Lot145129
- Amount recalled
- 4 units (US)
Where it was sold
Why it was recalled
Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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