Exactech recalls specific knee surgery systems due to vacuum bag loss risk. Affected units have catalog numbers 02-012-35-5009 and serial numbers A649282/A649289. No remedy stated in recall notice.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Exactech is recalling certain knee surgery systems (catalog numbers 02-012-35-5009) because vacuum bags may lose vacuum, potentially causing issues during surgery. This recall matters because the vacuum loss could affect surgical procedures if the system is used without proper vacuum function.
The vacuum bag in the knee system may lose vacuum pressure, which could lead to improper surgical function. This risk occurs during the procedure when the system is being used, potentially affecting the surgical outcome if the vacuum fails.
Surgical teams using Exactech Optetrak Logic PS Knee Systems with the specified catalog numbers and serial numbers are affected. Patients undergoing knee surgery with this system may be at risk if the vacuum bag fails during procedure.
Check for catalog number 02-012-35-5009 and serial numbers A649282 or A649289 on the device packaging or label. This recall applies to specific models sold with these identifiers.
Verify the catalog number and serial numbers on the device to confirm if it is affected.
The recall notice does not state any remedy or fix for the vacuum loss issue.
Check for catalog number 02-012-35-5009 and serial numbers A649282 or A649289 on the device packaging or label.
The recall notice does not specify any action steps for affected products.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0584-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0584-2024 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.
