FDA (Devices) recall action 82759
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Exactech is recalling two units of Opteform Allograft Discs because they were potentially exposed to higher temperatures than documented due to a cold storage equipment failure.
Exactech is recalling three units of Opteform Allograft Discs because they were potentially exposed to higher temperatures than documented due to cold storage equipment failure.
Exactech, Inc. is recalling two units of Opteform Allograft Discs because they were potentially exposed to higher temperatures than documented due to a cold storage equipment failure.