FDA-Device2021-04-21Class II
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.
Arthrex, Inc.
Hazard
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
Sold states
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.
Affected count
32 units
Manufactured in
1370 Creekside Blvd, N/A, Naples, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1380-2021Don't want to check this manually?
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