Arthrex, Inc. recalls Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
- Recall date
- February 24, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1310-2021
- FDA classification
- Class II
- Brand / firm
- Arthrex, Inc.
- Sold / distributed
- US Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas.
Why it was recalled
The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
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