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.
The devices may be packaged with the wrong reamer size.
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.
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.
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.
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).
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.
The devices may be packaged with the wrong reamer size, which could lead to incorrect surgical procedures if the wrong size is used.
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).
No, but you should verify the reamer size before use to avoid incorrect surgical procedures.
We’ve drafted a message you can send Arthrex to request your refund or repair — edit it as you like.
Subject: Recall Z-0465-2023 — Arthrex Arthrex Hello, I own a Arthrex that is covered by recall Z-0465-2023 from Arthrex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
