Exactech recalls specific shoulder arthroplasty humeral liners due to packaging that lacks an Ethylene Vinyl Alcohol (EVOH) 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 shoulder replacement humeral liners (model numbers 320-40-00 and 320-40-03) because their packaging does not include the required Ethylene Vinyl Alcohol (EVOH) oxygen barrier layer. This could lead to compromised product integrity, though the recall does not specify immediate safety risks.
The packaging for these humeral liners is nonconforming because it lacks an additional oxygen barrier layer made of Ethylene Vinyl Alcohol (EVOH). This could potentially affect the product's integrity over time, but the recall does not indicate immediate safety hazards.
Patients who own or use the recalled Exactech Equinoxe Humeral Liner models (320-40-00 and 320-40-03) for shoulder arthroplasty procedures. The risk is low as the hazard relates to packaging integrity rather than direct safety.
Check if your Exactech Equinoxe Humeral Liner has model numbers 320-40-00 or 320-40-03. The specific serial numbers listed in the recall are provided in the product description.
Verify your Exactech Equinoxe Humeral Liner model number and serial numbers against the list provided in the recall.
The packaging for these humeral liners does not meet the established specification because it lacks an Ethylene Vinyl Alcohol (EVOH) oxygen barrier layer.
The recall states the packaging is nonconforming but does not indicate any immediate safety risks or injuries. The hazard relates to product integrity rather than direct safety.
Check your product details against the list of affected model numbers and serial numbers provided in the recall. No specific action is required beyond verification.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1420-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1420-2024 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.
