Exactech recalls Vantage Ankle System models 350-21-04 and 350-22-03 due to vacuum bag loss. 3 complaints reported for 4 devices. No remedy specified in official notice.
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 ankle surgery systems because some units had vacuum bag failures. This could lead to improper surgical outcomes if the vacuum bag loses its seal during procedures.
The vacuum bag in these ankle systems can lose its seal during surgery, potentially causing the device to malfunction. This could lead to improper surgical outcomes if the vacuum bag fails to maintain its seal.
Patients who received the Exactech Vantage Ankle System with catalog numbers 350-21-04 or 350-22-03 are affected. Surgeons and medical teams using these specific models are most at risk.
Check for catalog numbers 350-21-04 or 350-22-03 on the device packaging. Serial numbers for model 350-21-04 start with A644020, and for model 350-22-03, serial numbers range from A641653 to A641672.
Verify the catalog number and serial numbers on the device packaging to confirm if it is part of the recall.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
The official recall notice does not specify a remedy, so no action is required beyond checking if your device is part of the recall.
Look for catalog numbers 350-21-04 or 350-22-03 on the packaging. Model 350-21-04 has serial number A644020, and model 350-22-03 has serial numbers from A641653 to A641672.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0587-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0587-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
