FDA Device recall Z-1310-2021
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures
- FDA Device
- Class II
- terminated
- Published 2021-04-07
On 2021-04-07 the FDA classified a Class II recall of Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures by Arthrex, citing the color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1310-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-24 |
| Published | 2021-04-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Arthrex |
| Distribution | US |
Product
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Reason
The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
Identifiers
| code_info | Product Code AR-8770-02, Lot Number 032052 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1310-2021%22
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