Exactech recalls specific Equinoxe Glenoid implants due to packaging lacking an oxygen barrier layer (EVOH), which may affect long-term stability. Affected items have serial numbers listed in the recall notice.
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Exactech is recalling certain Equinoxe Glenoid implants that were packaged without an additional oxygen barrier layer (EVOH). This packaging defect could potentially affect the long-term stability of the implants. Consumers should check if their implant matches the listed serial numbers and contact Exactech for guidance.
The packaging of these implants was nonconforming because it lacked an Ethylene Vinyl Alcohol (EVOH) layer, which is a critical oxygen barrier. This could lead to potential degradation of the implant material over time, affecting long-term stability.
Patients who received the affected Exactech Equinoxe Glenoid implants (specifically the small, medium, and large sizes) are likely affected. The risk is low as the packaging issue does not cause immediate harm but may impact long-term stability.
Check if your implant has the model name 'Exactech Equinoxe Glenoid, Keeled, Cemented, Mates with 38, 41, 44 head, alpha curvature' and the specific serial numbers listed in the recall notice (e.g., 0745683, 0747928, etc.).
Identify if your implant matches the model name and serial numbers listed in the recall notice.
The packaging lacks an Ethylene Vinyl Alcohol (EVOH) layer, which is a critical oxygen barrier. This could potentially affect the long-term stability of the implant over time.
If your implant does not match the specific model and serial numbers listed in the recall, there is no action required.
Check the model name and serial numbers against the list provided in the recall notice (e.g., 0745683, 0747928, etc.).
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1402-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1402-2024 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.
