FDA-Device2017-01-18Class II
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.
Acumed LLC
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.
Sold states
distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.
Affected count
83 units distributed in the US
Manufactured in
5885 NW Cornelius Pass Rd, Hillsboro, OR, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1019-2017Don't want to check this manually?
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