Exactech recalls specific shoulder replacement implants due to packaging lacking an oxygen barrier layer, which may not meet safety standards. Affected items include certain sizes and serial numbers.
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 implant models 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 specify immediate risks to users.
The packaging for these implants lacks an additional oxygen barrier layer (EVOH) that's supposed to be in the vacuum bags. This could mean the packaging doesn't meet safety standards, but the recall doesn't specify immediate risks to users.
Patients who received the recalled Exactech Equinoxe Glenoid implants with the specified sizes and serial numbers are affected. Surgeons and medical facilities that used these implants are also at risk.
Check if your implant is labeled as Exactech Equinoxe Glenoid, Posterior Augment, Pegged, Cemented, 8o, Left, with specific head sizes (38, 41, 44, 47 for small; 41, 44, 47, 50 for medium; etc.) and the listed serial numbers.
Verify your implant's model, size, and serial number against the list provided in the recall notice.
The recall does not state that the implants are unsafe for use; it only indicates packaging issues that may not meet safety standards.
Check the model, size, and serial numbers listed in the recall notice to see if your implant matches the affected items.
The recall does not specify any action steps beyond checking if your implant matches the affected list.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1406-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1406-2024 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.
