FDA-Device2021-04-07Class II

Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.

Arthrex, Inc.
Hazard

The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.

Sold states
US Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas.
Affected count
9 units
Manufactured in
1370 Creekside Blvd, Naples, FL, United States
Products
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1310-2021

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