Exactech recalls ARTHROFOCUS Polyethylene Tibial Inserts (model 256-12-XX, 256-13-XX) due to vacuum bags lacking an oxygen barrier layer. Consumers should check serial numbers listed in the recall notice.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Exactech is recalling certain ARTHROFOCUS Polyethylene Tibial Inserts because the vacuum packaging may not have an oxygen barrier layer. This could lead to the inserts degrading over time, though the recall does not specify a risk of injury or harm to users.
The vacuum bags used for packaging the inserts lacked an additional oxygen barrier layer. This could allow oxygen to penetrate the packaging over time, potentially causing the polyethylene material to degrade. However, the recall does not indicate that this degradation poses a risk of injury or harm to users.
Patients who received the recalled ARTHROFOCUS Polyethylene Tibial Inserts (model 256-12-XX or 256-13-XX) during surgery. The risk is low as the hazard relates to material degradation over time rather than immediate injury.
Check the product model numbers (256-12-XX or 256-13-XX) and serial numbers listed in the recall notice. The inserts were sold starting from February 7, 2022, and include specific serial numbers like 1208624, 1208625, etc.
Verify the model number and serial numbers listed in the recall notice to confirm if your inserts are affected.
The vacuum bags used for packaging the inserts lacked an additional oxygen barrier layer, which could lead to material degradation over time.
The recall does not indicate that the degradation poses a risk of injury or harm to users.
Check the model number and serial numbers listed in the recall notice to confirm if your inserts are affected. No specific action is required beyond verification.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0027-2022 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0027-2022 from Exactech. 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.
