Home / Recalls / Medical Devices
Acumed LLC recalls OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium
Recalled January 18, 2017 · FDA recall Z-1019-2017 · Acumed
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. · FDA Class II
Units
83 units distributed in the US
Sold at
distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.
Description
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.
Product
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.
Manufacturer(s)
Acumed LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →