Exactech recalls specific shoulder implant models due to packaging lacking an oxygen barrier layer, which may affect long-term performance. Affected units include item numbers 320-40-10 and 320-40-13 with listed 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 certain shoulder implants (Equinoxe Constrained Humeral Liner) because their packaging does not include the required oxygen barrier layer. This could potentially lead to long-term performance issues with the implant over time.
The packaging for these implants was missing an additional oxygen barrier layer (EVOH) that is required by the manufacturer's specifications. This could potentially allow oxygen to permeate the packaging, which might affect the long-term stability of the UHMWPE material used in the implants over time.
Patients who received the Exactech Equinoxe Constrained Humeral Liner implants with item numbers 320-40-10 or 320-40-13 are likely affected. Surgeons and medical facilities that used these specific models during shoulder arthroplasty procedures are at the highest risk.
Check if your implant has item numbers 320-40-10 or 320-40-13. Look for the specific serial numbers listed in the recall notice, which are provided in the product description. These implants were used in shoulder arthroplasty procedures.
Review the item numbers and serial numbers listed in the recall notice to confirm if your implant is affected.
The packaging for these implants does not include the required oxygen barrier layer (EVOH), which could affect long-term performance of the UHMWPE material.
Check if your implant has item numbers 320-40-10 or 320-40-13 and the specific serial numbers listed in the recall notice.
The recall does not specify a remedy, so you should contact Exactech directly for further guidance.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1421-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1421-2024 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.
