Exactech recalls specific knee implants due to vacuum bag loss. Affected units may have internal vacuum failure causing improper function. Contact for remedy details.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Exactech is recalling three specific knee implant models because they may lose vacuum in the inner bag, which could cause improper function during surgery. This is a serious issue for patients receiving these implants.
The inner vacuum bag in these knee implants may lose vacuum pressure, causing improper function during surgery. This could lead to incorrect joint alignment or movement. The issue has been reported in three devices but has not caused injuries.
Patients who received the Exactech Optetrak Logic Knee System with the listed catalog numbers and serials are affected. Surgeons and medical staff using these implants during procedures are at risk.
Check for catalog numbers: 02-012-47-3011, 02-012-47-5009, 02-012-47-5011, or 02-012-65-3013. Also look for serial numbers: A676497, A641353, A641341, or A655561.
Verify your Exactech Optetrak Logic Knee System has one of the listed catalog numbers or serial numbers.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Check your product details against the listed catalog numbers and serial numbers. Contact Exactech for further instructions.
The recall reports no injuries, but improper function could occur 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-0583-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0583-2024 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.