Exactech recalls OPTETRAK Advanced Patella 3 Peg Implant models with out-of-spec vacuum packaging. Affected items may have compromised UHMWPE knee components.
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 knee implants that came in vacuum bags not meeting quality specifications. These components could have manufacturing defects that might affect safety during surgery.
The recall involves knee patella components packaged in vacuum bags that don't meet quality specifications. This could mean the UHMWPE material might not be properly manufactured, potentially affecting the implant's safety during surgical procedures.
Patients who received the recalled OPTETRAK knee implants during surgery are most at risk. The recall applies to specific model sizes and lot numbers produced by Exactech.
Check if your OPTETRAK Advanced Patella 3 Peg Implant has model numbers 200-07-26 (26mm), 200-07-29 (29mm), 200-07-32 (32mm), or 200-07-35 (35mm). Look for specific lot numbers listed in the recall notice.
Identify your implant's model number and lot numbers to determine if it's affected by this recall.
The recall requires checking if your implant matches the affected model numbers and lot numbers listed. If it does, you should contact Exactech for further instructions.
Check your implant's model number (200-07-26, 200-07-29, 200-07-32, or 200-07-35) and lot numbers against the list provided in the recall notice.
The recall states the components were packaged in out-of-spec vacuum bags, but the official notice doesn't specify injury risks or how this affects safety during surgery.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-2158-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-2158-2024 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.
