Exactech recalls OPTETRAK Comprehensive Knee Systems with vacuum-packed inserts lacking an oxygen barrier layer. Affected models include 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX series. No immediate injury risk reported, but potential for long-term issues with joint implants.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Exactech is recalling specific models of OPTETRAK Comprehensive Knee Systems because the inserts were packaged in vacuum bags without an additional oxygen barrier layer. This could lead to long-term issues with the joint implants over time, though no injuries have been reported yet.
The vacuum bags used to package the knee inserts did not have an extra oxygen barrier layer. This could allow oxygen to enter the packaging over time, potentially causing the inserts to degrade or become less effective in the long term. However, the recall does not indicate immediate injury risks.
Patients who received the recalled OPTETRAK knee implants between 2022 and present. The recall covers specific model numbers (252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX) manufactured with vacuum bags lacking an oxygen barrier.
Check if your OPTETRAK Comprehensive Knee System includes model numbers starting with 252-12-XX, 252-13-XX, 252-22-XX, or 252-23-XX. The product was sold starting in 2022.
Look for the model number on your knee implant packaging or device label. If it starts with 252-12-XX, 252-13-XX, 252-22-XX, or 252-23-XX, it is affected.
Reach out to Exactech directly for guidance on next steps. They may provide a replacement or repair option.
The recall indicates a potential long-term issue with the implants, but no injuries have been reported yet. The hazard is not immediate.
Check your model number. If it starts with 252-12-XX, 252-13-XX, 252-22-XX, or 252-23-XX, it is affected.
No immediate action is required, but you should contact Exactech to confirm if your model is affected and get guidance.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0020-2022 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0020-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
