Exactech, Inc. recalls Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45

Recall date

April 26, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1689-2019

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

OK, VA, FL

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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