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Arthrex, Inc. recalls Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and f
Recalled April 21, 2021 · FDA recall Z-1380-2021 · Arthrex
Hazard
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts. · FDA Class II
Units
32 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of GA, LA, CA, FL, OR, TX and the countries of India, Russia, Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico.
Description
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
Product
Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
Manufacturer(s)
Arthrex, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →