Exactech recalls specific OPTETRAK Three Peg Patella knee components due to vacuum bags not meeting specifications, which may cause improper fit during surgery.
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Exactech is recalling certain OPTETRAK Three Peg Patella knee implants because they were packaged in vacuum bags that don't meet quality standards. This could lead to improper surgical fit if used in procedures.
The knee components were packaged in vacuum bags that don't meet specifications. This could cause improper fit during surgery, potentially leading to complications if the implant doesn't align correctly with the patient's anatomy.
Patients who received the recalled OPTETRAK Three Peg Patella knee implants with specific item numbers and lot numbers listed in the recall notice. Surgeons and medical facilities using these components are most at risk.
Check the item number on the packaging (200-02-26, 200-02-29, 200-02-32, 200-02-35, 200-02-38, or 200-02-41) and the lot numbers listed in the recall notice. These components were sold with specific UDI/DI numbers and lot numbers.
Identify the item number and lot numbers on the packaging to confirm if your component is recalled.
No, the recall does not require immediate discontinuation. The hazard is related to packaging specifications, not active failure during use.
The recall does not specify a remedy, so contact Exactech directly for guidance on next steps.
The recall states the components may not fit properly during surgery, but no specific injury risks are mentioned.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-2155-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-2155-2024 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.
