Arthrex Small Joint OATS Sets Recalled Due to Wrong Reamer Size Packaging
Arthrex recalls two small joint OATS sets (6mm and 8mm) that may be packaged with the wrong reamer size. Consumers should check product labels for batch numbers to determine if affected.
Lower-risk recall
The devices may be packaged with the wrong reamer size.
Contact the company
What happened, in plain English
Arthrex is recalling two small joint OATS sets (6mm and 8mm) because they might come with the wrong reamer size in the packaging. This could lead to incorrect surgical procedures if used without proper verification. Read more at govinfonow.com/recall/59725-arthrex-small-joint-oats-sets-recalled-due-to-wrong-reamer.
Source Summary by GovInfoNow · govinfonow.com/recall/59725-arthrex-small-joint-oats-sets-recalled-due-to-wrong-reamer · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0465-2023
Cite this page
“Arthrex Small Joint OATS Sets Recalled Due to Wrong Reamer Size Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59725-arthrex-small-joint-oats-sets-recalled-due-to-wrong-reamer. Based on FDA recall #Z-0465-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0465-2023%22&limit=1).
Why it’s dangerous
The devices may be packaged with the wrong reamer size, which could lead to incorrect surgical procedures if the wrong size is used during procedures. This risk is specific to the packaging and not the device itself.
Who’s affected
Surgical professionals and medical facilities using Arthrex Small Joint OATS sets may be affected. Those using the products without verifying the reamer size are at higher risk of incorrect surgical procedures.
How to tell if you have this one
Check the product label for the model number (AR-8981-06S for 6mm or AR-8981-08S for 8mm) and batch number (2003118198 for 6mm or 2014118685 for 8mm).
- Brand
Arthrex- Category
Medical device
What to do — step by step
Check Product Label
Look for the model number (AR-8981-06S for 6mm or AR-8981-08S for 8mm) and batch number (2003118198 or 2014118685) to confirm if the product is affected.
Where it went and when
Where it was distributed
Distributed in 20 states, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arkansas, California, Colorado, Florida, Illinois, Iowa, Louisiana, Maryland, Massachusetts, Michigan, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia.
Recall timeline
FDA published this recall 42 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0465-2023 (November 2, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0465-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.