Exactech recalls Novation XLE hip implants (item numbers 140-22-70 to 148-40-55) due to missing Ethylene Vinyl Alcohol (EVOH) barrier layer. This could lead to improper function or failure of the implant.
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Exactech is recalling specific models of Novation XLE hip implants because they lack an Ethylene Vinyl Alcohol (EVOH) barrier layer. This defect may cause the implant to fail or not function properly, potentially leading to complications after surgery.
The implants lack a critical Ethylene Vinyl Alcohol (EVOH) barrier layer, which is necessary to prevent the internal components from interacting with the body's fluids. Without this layer, the implant may not function correctly and could lead to failure or complications.
Individuals who own or use the recalled Novation XLE hip implants (item numbers 140-22-70 to 148-40-55) are affected. Surgeons who have implanted these devices in patients are most at risk for complications.
Check for the item numbers listed in the recall: 140-22-70 to 148-40-55. These are specific hip implant models sold by Exactech for hip replacement surgery.
Review the item numbers and serial numbers listed in the recall to confirm if your implant is affected.
The recall is due to the lack of an Ethylene Vinyl Alcohol (EVOH) barrier layer, which is necessary for proper function of the implant.
The recall does not specify a remedy, so no action is required unless you have the specific item numbers listed.
Check the item numbers and serial numbers listed in the recall (140-22-70 to 148-40-55) to see if your implant matches.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1166-2025 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1166-2025 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.
