Exactech recalls specific shoulder implant models due to noncompliant packaging that lacks an oxygen barrier layer, potentially affecting product integrity.
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 shoulder implants (Equinoxe Glenoid Posterior Augment) because their packaging does not meet safety standards. This defect could lead to improper product integrity, though no injuries have been reported.
The packaging lacks an additional oxygen barrier layer (EVOH) that protects the implants from moisture and degradation. This could cause the implants to become less effective or fail over time, but the risk is not immediate or severe.
Patients who received these specific shoulder implants during surgery are likely affected. Surgeons and medical facilities using these implants for cemented shoulder replacements are at the highest risk.
Check for the product names: Exactech Equinoxe Glenoid Posterior Augment, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY. Look for specific item numbers (314-04-32 to 314-04-35) and serial numbers listed in the recall notice.
Review the item numbers and serial numbers listed in the recall notice to confirm if your implant is affected.
The packaging does not meet established specifications because it lacks an additional oxygen barrier layer (EVOH), which could affect product integrity.
No immediate action is required; the recall is for product verification, not immediate use cessation.
Check the item numbers (314-04-32 to 314-04-35) and serial numbers listed in the recall notice.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1409-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1409-2024 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.
