Exactech recalls two specific model numbers of tibial inserts due to potential vacuum loss in the inner bag, which may affect surgical use. Affected units have unique serial numbers.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Exactech is recalling two specific model numbers of tibial inserts because they may lose vacuum in the inner bag during use. This could lead to improper function in surgical procedures.
The inner vacuum bag may lose vacuum during use, potentially causing the insert to not function properly in surgical procedures. This could lead to improper joint alignment or movement.
Orthopedic surgeons and medical professionals using these inserts for joint replacements are most at risk. Patients using these implants are not directly affected by the recall.
Check for catalog numbers 350-41-23 or 350-42-03. Serial numbers for model 350-41-23 is A658148, and for model 350-42-03 are A688864 through A688882.
Review the catalog number and serial numbers to confirm if your insert is affected.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Catalog numbers 350-41-23 and 350-42-03.
Check for serial numbers: A658148 for model 350-41-23, and A688864 through A688882 for model 350-42-03.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0588-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0588-2024 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.
