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FDADecember 5, 2016device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

acumed

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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