Exactech recalls specific 46mm humeral liners for reverse shoulder surgery due to nonconforming packaging that lacks an 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 46mm humeral liners for reverse shoulder surgery because their packaging does not meet specifications. The packaging lacks an Ethylene Vinyl Alcohol (EVOH) oxygen barrier layer, which could lead to improper storage conditions.
The packaging for these humeral liners does not include an additional oxygen barrier layer of Ethylene Vinyl Alcohol (EVOH). This could result in improper storage conditions, potentially affecting the liner's integrity over time.
Patients who received the affected Exactech Equinoxe Reverse Shoulder 46mm humeral liners with specific serial numbers listed in the recall notice. Surgeons and medical facilities using these items are also affected.
Check if your Exactech Equinoxe Reverse Shoulder 46mm humeral liner has a serial number listed in the provided recall notice (e.g., 0984597, 0984599, etc.). The affected items are identified by specific item numbers: 320-46-00 and 320-46-03.
Review the list of serial numbers provided in the recall notice to determine if your Exactech Equinoxe Reverse Shoulder 46mm humeral liner is affected.
The packaging lacks an Ethylene Vinyl Alcohol (EVOH) oxygen barrier layer, which is required to meet the established packaging specification.
Compare your humeral liner's serial number with the list of affected serial numbers provided in the recall notice (e.g., 0984597, 0984599, etc.).
The recall notice does not specify a remedy, so affected items should be checked against the list of serial numbers and handled according to the manufacturer's guidance.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1424-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1424-2024 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.
