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.

Reason: 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.

Code information: lot 549/12.001. Part number 65-0210-S.

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