Exactech recalls certain shoulder implants due to packaging lacking an oxygen barrier layer, which may not meet specifications. Affected items include specific model numbers and serial ranges for cemented use only.
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 Glenoid Augments) because their packaging doesn't have the required oxygen barrier layer. This could mean the packaging doesn't meet safety standards, but the recall doesn't mention immediate risks to users.
The packaging for these implants is nonconforming because it lacks an additional oxygen barrier layer (EVOH) that's supposed to be part of the packaging specification. This could mean the packaging doesn't meet the required safety standards, but the recall doesn't describe any immediate hazards to users.
Patients who received these specific shoulder implants for cemented use only. The most at-risk individuals are those who have the listed model numbers and serial ranges.
Check if your implant has the model numbers 314-06-32 to 314-06-35 and the listed serial numbers. These are for cemented shoulder replacements.
Review the model number and serial numbers on your implant to see if they match the affected ranges listed in the recall.
The recall does not state that the implant is unsafe for use; it only identifies packaging issues. You do not need to stop using it unless instructed otherwise by your doctor.
The recall does not provide a remedy, so contact your surgeon to discuss whether the implant needs replacement or further action.
The recall does not mention any immediate risks to users from the packaging issue.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1411-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1411-2024 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.
