Exactech recalls Optetrak Knee System models with catalog numbers 200-02-26 to 208-24-13 due to potential loss of vacuum in the inner bag. Affected users should 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 models of their Optetrak Knee System because some devices may lose vacuum in the inner bag. This could lead to improper function during surgery. Affected users should contact Exactech for instructions.
The inner vacuum bag may lose vacuum during use, which could cause the device to malfunction. This might lead to improper surgical outcomes but does not typically cause immediate injury.
Medical professionals using the Exactech Optetrak Knee System for knee surgeries are most likely affected. Patients using these devices are not directly at risk.
Check the catalog number on the device, which ranges from 200-02-26 to 208-24-13. Also look for the corresponding serial numbers listed in the recall notice.
Reach out to Exactech directly to confirm if your device is affected and get instructions for next steps.
The recall includes Exactech Optetrak Knee System models with catalog numbers 200-02-26 through 208-24-13.
Check the catalog number on your device, which should be one of the listed numbers from 200-02-26 to 208-24-13.
No, the recall does not require immediate discontinuation. Contact Exactech for specific instructions.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0582-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0582-2024 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.
