Exactech recalls Opteform Allograft Discs (90mm x 5mm, 22cc) due to potential exposure to higher temperatures from cold storage equipment failure. 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 certain 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 performance in medical procedures.
The discs could have been exposed to higher temperatures than specified during cold storage, potentially affecting their integrity and safety. This risk is related to the cold storage equipment failure, not normal use conditions.
Medical professionals using these discs for surgical procedures are most at risk. Patients receiving these discs during surgery may be affected if the discs were compromised.
Check for the catalog number 600-03-90 and serial numbers T31977961, T31977962, or T31977968 on the disc packaging or label. These specific units were recalled due to cold storage equipment issues.
Look for the catalog number 600-03-90 and serial numbers T31977961, T31977962, or T31977968 on the disc packaging or label.
The discs may have been exposed to higher temperatures than documented due to a failure in the cold storage equipment.
Check the disc packaging for the catalog number 600-03-90 and serial numbers T31977961, T31977962, or T31977968. If you have these, contact Exactech for further instructions.
The recall is due to potential temperature exposure during cold storage, which could affect the disc's integrity. However, the hazard level is low risk as it does not involve immediate danger in normal use.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1690-2019 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1690-2019 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.
