FDA Device recall Z-0465-2023
Small Joint OATS Set, REF AR-8981-06S, 6mm
- FDA Device
- Class II
- ongoing
- Published 2022-12-14
On 2022-12-14 the FDA classified a Class II recall of Small Joint OATS Set, REF AR-8981-06S, 6mm by Arthrex, citing the devices may be packaged with the wrong reamer size.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0465-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-02 |
| Published | 2022-12-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Arthrex |
| Distribution | AL, AR, CA, CO, FL, IA, IL, LA, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, UT, VA |
Product
Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.
Reason
The devices may be packaged with the wrong reamer size.
Identifiers
| code_info | AR-8981-06S, batch 2003118198, UDI/DI 00888867056817; and AR-8981-08S, batch 2014118685, UDI/DI 00888867056824. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0465-2023%22
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