Recall Z-1310-2021 ยท HTW Bit, Drill
Arthrex, Inc.
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
| Date | Feb 24, 2021 |
| Status | Terminated |
| Reason | The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color. |
| Root cause | Under Investigation by firm |
| Action | Consignees were notified via e-mail with URGENT: RECALL NOTIFICATION dated 02/23/2021. The letter identified affected product, reason for recall, and instructed consignee to immediately discontinue use, sale, and distribution of the product as well instructions for handling of affected product. |
| Quantity | 9 units |
| Distribution | US Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.