Exactech recalls Opteform Allograft Discs (30mm, 45mm, 90mm) due to potential cold storage equipment failure causing higher temperatures than specified. Affected units have specific catalog and serial numbers.
The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
Exactech is recalling Opteform Allograft Discs that may have been exposed to higher temperatures than intended due to cold storage equipment failure. This could affect the disc's safety and effectiveness for medical use.
The discs were potentially exposed to higher temperatures than documented in the instructions because of a cold storage equipment failure. This could compromise the disc's integrity and safety for medical use.
Patients using these discs for medical procedures are affected. Healthcare providers who received the discs from the manufacturer are most at risk.
Check for catalog number 600-03-30 and serial numbers T31634510 or T31788559. The discs are 30mm, 3mm, 2cc in size.
Verify the catalog number and serial numbers to confirm if your disc is affected.
The recall indicates potential temperature exposure, but the discs may still be safe for use if properly stored. Exactech has not specified a remedy.
Exactech has not provided a specific remedy for this recall, so check the product details to confirm if it's affected.
Look for catalog number 600-03-30 and serial numbers T31634510 or T31788559 on the disc packaging.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1688-2019 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1688-2019 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.
