Exactech recalls certain shoulder arthroplasty implants due to nonconforming packaging that lacks an oxygen barrier layer. This could lead to packaging failure during storage. Affected items have specific model numbers and 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 specific shoulder implants (Equinoxe CAGE Glenoid Posterior Augment) because their packaging doesn't meet specifications. The packaging lacks an Ethylene Vinyl Alcohol (EVOH) oxygen barrier layer, which could cause the packaging to fail during storage. This is a packaging issue, not a safety hazard in normal use.
The packaging of these implants is nonconforming because it lacks an additional oxygen barrier layer (EVOH) that meets established specifications. This could potentially lead to packaging failure during storage, but it does not affect the implant's safety or function in the body.
Patients who received the recalled shoulder implants (Equinoxe CAGE Glenoid Posterior Augment) with specific model sizes and serial numbers listed in the recall notice. The risk is minimal as this is a packaging issue that doesn't affect the implant's safety or function.
Check if your implant is labeled as 'Exactech Equinoxe CAGE Glenoid Posterior Augment, Cemented, Left' with specific model sizes (38, 41, 44, 47 head, Small; 41, 44, 47, 50 head, Medium; etc.) and the corresponding serial numbers listed in the recall notice.
Verify if your implant matches the specific model sizes and serial numbers listed in the recall notice.
No, this is a packaging issue that does not affect the implant's safety or function in the body. The packaging defect is not a hazard in normal use.
You do not need to take any action unless your implant matches the specific model sizes and serial numbers listed in the recall notice.
If your implant matches the recall criteria, 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-1414-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1414-2024 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.
