medical Class II Updated 2019-06-05

Exactech, Inc. recalls Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600

Recalled Product

Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45


Hazard / Issue

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.

Issued by

FDA

Affected States: OK, VA, FL
Lot/Code Info: UDI 10885862093219 Serial Numbers: T32309666, T32309672
View official government recall

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