Exactech recalls shoulder implants with catalog numbers 314-23-02 to 314-24-35 due to potential loss of vacuum in inner bag. Affected users should check serial numbers and contact Exactech for details.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Exactech is recalling specific shoulder implant models (catalog numbers 314-23-02 to 314-24-35) because some units may lose vacuum in the inner bag. This could lead to improper function of the implant, but no injuries have been reported.
The inner vacuum bag in some implants may lose vacuum, which could cause the implant to not function properly. This is a mechanical issue but does not involve immediate injury risks.
Patients who received the Exactech Equinoxe Shoulder System implants with the listed catalog numbers and serial numbers are affected. Those with the specific models are most at risk.
Check the catalog number on the implant packaging or label. The affected models have catalog numbers from 314-23-02 to 314-24-35 and specific serial numbers listed in the recall notice.
Review the catalog number and serial numbers listed in the recall notice to confirm if your implant is affected.
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Check the catalog number on your implant packaging or label. Affected models have catalog numbers from 314-23-02 to 314-24-35 with specific serial numbers listed in the recall notice.
Contact Exactech directly to confirm your implant's status 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-0580-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0580-2024 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.