Small Joint OATS Set — Class II medical device recall Z-0465-2023
Ongoing recall by Arthrex, Inc., reported 2022-12-14, distributed in AL, AR, CA, CO, FL, IA, IL, LA…. The devices may be packaged with the wrong reamer size.
| Recall number | Z-0465-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arthrex, Inc., Naples, FL, United States |
| Recall initiated | 2022-11-02 |
| Classified | 2022-12-08 |
| Reported by FDA | 2022-12-14 |
| Distributed | AL, AR, CA, CO, FL, IA, IL, LA, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, UT, VA |
| Countries outside the US | CA, CN, DE, EC, FI, FR, GB, PT, RU |
| Quantity | 123 units |
| UPC / GTIN / UDI-DI | 00888867056817, 00888867056824 |
| Lot numbers | 2003118198, 2014118685 |
| Model numbers | 6MM, 8MM, AR-8981-06S, AR-8981-08S |
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 for recall
The devices may be packaged with the wrong reamer size.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0465-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.