Reported Apr 21, 2021 · Terminated
Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and…
Arthrex, 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: Arthrex, Inc. · 1370 Creekside Blvd · Naples, FL · 34108-1945
Is this the product you have?
- Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0
- mm - Product Usageuse in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur
- Lot codes and dates
- Part numberAR-13200T-15.0
- Lot code12135408
- Amount recalled
- 32 units
Where it was sold
Why it was recalled
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
This product could cause temporary or reversible health problems — stop using it.
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