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Arthrex, Inc. recalls Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated
Recalled December 14, 2022 · FDA recall Z-0465-2023 · Arthrex
Hazard
The devices may be packaged with the wrong reamer size. · FDA Class II
Units
123 pieces
Sold at
Distribution was made to AL, AR, CA, CO, FL, IA, IL, LA, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, UT, and VA. There was no military/government distribution. Foreign distribution was made to Ecuador, Germany, Russia, Canada, China, Finland, France, Germany, Portugal, and the United Kingdom.
Description
The devices may be packaged with the wrong reamer size.
Product
Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.
Manufacturer(s)
Arthrex, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →