Exactech recalls certain Equinoxe Glenoid implants due to nonconforming 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 specific Equinoxe Glenoid implants that have packaging without an oxygen barrier layer. This defect could compromise the product's integrity, though it does not pose an immediate safety risk to users.
The packaging of these implants lacks an Ethylene Vinyl Alcohol (EVOH) oxygen barrier layer, which is required to maintain product integrity. This defect could lead to compromised implant quality over time, but it does not cause immediate injury or failure during normal use.
Patients who received the recalled Equinoxe Glenoid implants (specifically the 8o right side models with certain head sizes and item numbers) are affected. Surgeons and medical facilities that used these implants are also at risk.
Check if your implant has the model described: Exactech Equinoxe GLENOID, POSTERIOR AUGMENT, PEGGED, CEMENTED, 8o, RIGHT, with specific head sizes (38, 41, 44, 47 for small; 41, 44, 47, 50 for medium; etc.) and item numbers 314-02-32 to 314-02-35. The serial numbers listed in the recall are also unique identifiers.
Identify your implant's model, item number, and serial numbers to confirm if it is in the recall list.
No, the recall is for packaging defects that do not cause immediate injury. These implants can be used safely if they are not affected by the packaging issue.
Check if your implant matches the specific model, item numbers (314-02-32 to 314-02-35), and serial numbers listed in the recall notice.
The recall does not require immediate action. Contact Exactech directly to confirm if your implant is affected and follow their guidance.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1407-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1407-2024 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.
