Exactech recalls specific 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 certain glenoid implants for shoulder arthroplasty because their packaging does not meet specifications. This defect could compromise the implant's integrity during use.
The packaging lacks an additional oxygen barrier layer (EVOH) that is required by specification. This could potentially allow moisture or oxygen to degrade the implant material over time, but the hazard is not immediate or severe.
Patients who received these specific Exactech Equinoxe glenoid implants for shoulder surgery are affected. The risk is low as the defect relates to packaging, not direct harm to the implant.
Check if your implant has the model numbers 314-04-22 to 314-04-25 with the listed serial numbers or UDI/DI codes. These implants are for cemented shoulder arthroplasty procedures.
Review your implant's model number, serial numbers, and UDI/DI codes to confirm if it matches the recalled items listed in the notice.
The packaging does not meet the established specifications because it lacks an additional oxygen barrier layer (EVOH).
No, the recall is for packaging defects, not immediate safety risks. The implant can still be used as intended.
Check the model numbers (314-04-22 to 314-04-25) 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-1408-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1408-2024 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.
