Small Joint OATS Set, REF AR-8981-06S, 6mm recallZ-0465-2023 · Arthrex, Inc. · initiated Nov 2, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arthrex, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The devices may be packaged with the wrong reamer size.
FDA root cause category: Under Investigation by firm
What the company is doing
The recall notifications were initiated on 11/2/2022 via email. They described the product affected, reason for recall, and provided required actions for the different U.S. and OUS consignees. The U.S. distributor consignees were instructed to contact Field Logistics Services to arrange for return of the affected product. The direct customers (medical facilities) were to contact Arthrex Product Surveillance then they will be further instructed. No response forms were included.
Recall details
- Recall number
- Z-0465-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 2, 2022
- Posted by the FDA
- Dec 8, 2022
- Recalling firm
- Arthrex, Inc.
- Quantity
- 123 pieces
- Product code
- MDM
- Distribution
- Distribution was made to AL, AR, CA, CO, FL, IA, IL, LA, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, UT, and VA. There was no military/government distribution. Foreign distribution was made to Ecuador, Germany, Russia, Canada, China, Finland, France, Germany, Portugal, and the United Kingdom.
Product description
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.
Code information (models, lots, serial numbers)
AR-8981-06S, batch 2003118198, UDI/DI 00888867056817; and AR-8981-08S, batch 2014118685, UDI/DI 00888867056824.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Arthrex® AR-8981-08SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall3 reports
- Arthrex® AR-8981-06SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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