Exactech recalls specific shoulder implants due to nonconforming packaging that lacks oxygen barrier layer. Affected items have 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 certain shoulder implants (Equinoxe Glenoid Augments) because their packaging does not meet specifications. The packaging lacks an oxygen barrier layer that could potentially affect the implant's integrity over time.
The implants were packaged in vacuum bags without an additional oxygen barrier layer (EVOH). This could theoretically allow oxygen to permeate the packaging, potentially affecting the implant's long-term stability. However, the recall does not indicate immediate harm or injury.
Patients who received these specific shoulder implants during surgery are likely affected. The risk is low as the packaging issue does not cause immediate harm.
Check if your implant has a serial number listed in the provided range (e.g., 2579212, 2634987, etc.) or matches the item numbers 314-06-22 through 314-06-25. The product is for cemented shoulder replacements.
Review your implant's serial number and item number to confirm if it matches the affected range listed in the recall notice.
The packaging does not meet specifications as it lacks an additional oxygen barrier layer (EVOH) that could affect the implant's long-term stability.
No, the recall does not require immediate action. The hazard is low risk and does not cause immediate harm.
Check your implant's serial number against the list provided in the recall notice (e.g., 2579212, 2634987, etc.) or verify the item number (314-06-22 through 314-06-25).
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1410-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1410-2024 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.
