BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-1019-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-1019-2017
    Event ID
    75904
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Acumed LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 18, 2017
    Initiation Date
    December 5, 2016
    Classification Date
    January 12, 2017
    Termination Date
    March 22, 2017
    Address
    5885 NW Cornelius Pass Rd, Hillsboro, OR, 97124-9432, United States

    Description

    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 Info

    lot 549/12.001. Part number 65-0210-S.

    Distribution

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

    Quantity

    83 units distributed in the US