Acumed LLC recalls OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium…

Recall date

December 5, 2016

Source

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

Recall number

Z-1019-2017

FDA classification

Class II

Brand / firm

Acumed LLC

Sold / distributed

distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.

Why it was recalled

OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the sterilization dose used in production. Product sterilized at the site did not receive the minimum dose required per the new performance qualification.

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

What was recalled

OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.