Exactech recalls 320-36-00 to 320-46-13 models due to potential loss of vacuum in inner bag. Check serial numbers and GTINs for affected units.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Exactech is recalling specific models of their Equinoxe Reverse Shoulder System implants because some devices have experienced a loss of vacuum in the inner bag. This could lead to improper function of the implant.
The inner vacuum bag in some models may lose vacuum, which could cause the implant to not function properly. This is based on 3 complaints for 4 devices, indicating a potential issue but not a serious injury.
Patients who received the recalled Equinoxe Reverse Shoulder System implants between the listed catalog numbers and serial numbers. The risk is low as only 3 complaints were reported for 4 devices.
Check if your implant has catalog numbers a) 320-36-00 through n) 320-46-13. Look for the specific serial numbers and GTINs listed in the recall notice.
Review your implant's catalog number and serial numbers against the list provided in the recall notice.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Check your implant's catalog number and serial numbers against the list of affected models and serial numbers provided in the recall notice.
The recall notice does not specify a remedy.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0579-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0579-2024 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.
