Exactech recalls Alteon XLE hip implants with missing Ethylene Vinyl Alcohol (EVOH) barrier layer. Affected units include specific item numbers and serial numbers listed in the recall notice. Consumers should contact Exactech for details.
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Exactech is recalling certain Alteon XLE hip implants due to a missing Ethylene Vinyl Alcohol (EVOH) barrier layer. This defect could lead to improper function of the implant, though the recall does not specify a risk of serious injury or death in normal use. Affected units have specific item numbers and serial numbers listed in the recall notice.
The Alteon XLE implants lack the Ethylene Vinyl Alcohol (EVOH) barrier layer, which is critical for maintaining the integrity of the implant's structure and preventing premature failure. Without this layer, the implant may not function as intended, potentially leading to complications during the healing process.
Individuals who own or use the affected Alteon XLE hip implants, which include specific item numbers and serial numbers listed in the recall notice. The recall targets patients who have undergone hip replacement surgery using these implants.
Check for the specific item numbers listed in the recall, such as 140-22-70, 140-28-50, and others. Also, verify the serial numbers provided in the recall notice, which include a range of numbers like 6771453, 6771460, and others.
Review the item numbers and serial numbers listed in the recall notice to determine if your Alteon XLE hip implant is affected.
The Alteon XLE implants lack the Ethylene Vinyl Alcohol (EVOH) barrier layer, which is critical for maintaining the implant's structural integrity.
Check the item numbers and serial numbers listed in the recall notice, which include specific codes like 140-22-70 and serial numbers such as 6771453.
The recall does not specify a remedy, so affected users should contact Exactech directly for further instructions.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1167-2025 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1167-2025 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.
