Exactech recalls specific models of 36mm reverse shoulder humeral liners due to nonconforming packaging that lacks an oxygen barrier layer, potentially causing contamination.
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 36mm reverse shoulder humeral liners because their packaging does not meet specifications and lacks an Ethylene Vinyl Alcohol (EVOH) oxygen barrier layer. This defect could lead to contamination of the liners during storage.
The packaging for these humeral liners does not include an additional oxygen barrier layer made of Ethylene Vinyl Alcohol (EVOH), which is required by the established packaging specifications. This defect could allow contaminants to enter the packaging during storage, potentially causing contamination of the liners.
Patients who received the recalled Exactech Equinoxe Reverse Shoulder 36mm Constrained Humeral Liners with specific item numbers and serial numbers listed in the recall notice. Surgeons and medical facilities using these products are most at risk.
Check for the specific item numbers: 320-36-10 or 320-36-13, along with the listed serial numbers in the recall notice. These products were sold for shoulder arthroplasty procedures.
Review the item numbers and serial numbers listed in the recall notice to confirm if your product is affected.
The packaging for these humeral liners does not meet the established specifications because it lacks an Ethylene Vinyl Alcohol (EVOH) oxygen barrier layer.
The official recall notice does not specify a remedy, so no action is required beyond checking if your product matches the affected item numbers and serial numbers.
The recall addresses potential contamination risks from improper packaging, not direct injury or harm to users.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1417-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1417-2024 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.
