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Exactech, Inc. recalls Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
Recalled June 5, 2019 · FDA recall Z-1690-2019 · Exactech
Hazard
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. · FDA Class II
Units
3 units
Sold at
OK, VA, FL
Description
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.
Product
Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
Manufacturer(s)
Exactech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →