Z-1310-2021 Class II Terminated
FDA device recall Z-1310-2021 was initiated by Arthrex, Inc. on February 24, 2021 and is designated Class II. Reason for recall: The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color. The recall status is terminated (terminated May 2, 2023). Affected quantity: 9 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 7, 2021
- Initiation Date
- February 24, 2021
- Termination Date
- May 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Reason for Recall
The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
Distribution Pattern
US Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas.
Code Information
Product Code AR-8770-02, Lot Number 032052