Device product
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Z-1310-2021
Product summary
- Firm
- Arthrex, Inc.
- Event
- Event 87481
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 units
- Official record key
device-enforcement:Z-1310-2021
Official wording
Reason: The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
Code information: Product Code AR-8770-02, Lot Number 032052
Distribution pattern: US Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas.
Derived failure modes
-
Unknown
The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.