Exactech recalls Opteform Allograft Disc 45mm x 5mm (8cc) due to potential cold storage equipment failure causing higher temperatures than specified. Affected units have specific serial numbers and catalog 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 (45mm x 5mm, 8cc) because they might have been exposed to higher temperatures than intended due to cold storage equipment failure. This could affect the product's safety and effectiveness.
The discs may have been exposed to higher temperatures than documented in the product instructions due to a failure in cold storage equipment. This could impact the disc's integrity and safety during medical procedures.
Medical professionals using these discs for surgical procedures are most likely affected. Patients receiving the discs are at risk if the discs were improperly stored.
Check for the catalog number 600-03-45 and serial numbers T32309666 or T32309672. The product is sold under the brand Exactech.
Verify the catalog number 600-03-45 and serial numbers T32309666 or T32309672 to confirm if your disc is affected.
The Opteform Discs were potentially exposed to higher temperatures than documented due to a failure in cold storage equipment.
Check the catalog number and serial numbers to see if your disc is affected. If it is, contact Exactech for further instructions.
The recall is due to potential temperature exposure, but no specific injuries have been reported. The risk is low and related to product integrity during medical procedures.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1689-2019 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1689-2019 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.
