Exactech recalls specific reverse shoulder implants due to nonconforming packaging that lacks an oxygen barrier layer. Affected units have serial numbers listed in the recall notice. Consumers should contact Exactech for details.
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 reverse shoulder implants (Equinoxe REVERSE SHOULDER, 46mm Constrained Humeral Liner) because their packaging does not meet specifications. The packaging lacks an additional oxygen barrier layer (EVOH), which could lead to improper storage conditions.
The packaging for these implants does not include an EVOH (Ethylene Vinyl Alcohol) oxygen barrier layer. This could allow moisture or oxygen to enter the packaging, potentially affecting the implant's integrity over time.
Patients who received the affected implants (specifically models with item numbers 320-46-10 and 320-46-13) are likely affected. Surgeons and patients using these implants are at risk.
Check for the item numbers 320-46-10 or 320-46-13 on the implant packaging. Serial numbers listed in the recall notice (e.g., 0984536, 0984533, etc.) indicate affected units.
Review the implant's item number and serial numbers to confirm if it matches the recalled models (320-46-10 or 320-46-13).
Reach out to Exactech directly for assistance with the recall process and to determine if your implant is affected.
The packaging lacks an EVOH oxygen barrier layer, which could affect the implant's integrity over time.
Check for item numbers 320-46-10 or 320-46-13 and serial numbers listed in the recall notice.
Contact Exactech to confirm if your implant is affected and follow their instructions.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1425-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1425-2024 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.
