Exactech recalls Vantage Total Ankle System components (350-21-XX, 350-41-XX, 350-42-XX) due to vacuum bags lacking an additional oxygen barrier layer. Affected items have specific serial numbers listed in the recall notice.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Exactech is recalling certain Vantage Total Ankle System components because the vacuum packaging for these parts did not include an extra oxygen barrier layer. This could potentially lead to issues with the product's integrity over time, though the specific risk is not described as causing immediate harm. Consumers should check if their item matches the listed serial numbers and contact Exactech for guidance.
The vacuum bags used to package the polyethylene liner components lacked an additional oxygen barrier layer. This could allow oxygen to penetrate the packaging over time, potentially affecting the product's integrity. However, the recall does not specify that this causes immediate injury or serious harm.
Individuals who own or use the recalled Vantage Total Ankle System components (specifically the listed product lines and serial numbers) are most at risk. The recall targets medical implants used in ankle surgeries.
Check if your Vantage Total Ankle System includes the listed product lines (350-21-XX, 350-41-XX, 350-42-XX) and the specific serial numbers provided in the recall notice. The recall was initiated on February 7, 2022.
Verify if your Vantage Total Ankle System component matches the product lines (350-21-XX, 350-41-XX, 350-42-XX) and the listed serial numbers in the recall notice.
The recall states that the vacuum bags lacked an additional oxygen barrier layer, which could potentially affect the product's integrity over time. However, the recall does not specify that this causes immediate injury or serious harm.
Check if your Vantage Total Ankle System component matches the product lines (350-21-XX, 350-41-XX, 350-42-XX) and the specific serial numbers listed in the recall notice.
Contact Exactech directly for guidance on next steps. The recall does not specify a remedy or action to take beyond checking if your item is affected.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0024-2022 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0024-2022 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.
