BEUDAMED
    FDA Recall Terminated

    OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc, 05-6010-100 10cc, 05-6010-150 15cc & 05-6010-300 30cc

    Recall: Z-0423-2007 · Initiated August 31, 2006

    Recall

    Recall Number
    Z-0423-2007
    Event Number
    36974
    Firm
    Teknimed SA 11 Rue Apollo L France
    FEI Number
    3003854593
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 31, 2006
    Posted
    February 22, 2007
    Terminated
    April 23, 2012

    Description

    OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc, 05-6010-100 10cc, 05-6010-150 15cc & 05-6010-300 30cc

    Reason

    The firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box.

    Action

    Teknimed notified IsoTis OrthoBiologics via electronic recall letter dated August 31, 2006. IsoTis was instructed to notify their consignees of this field correction and they were asked to be responsible for identifying and making any corrections necessary at the medical user level. Teknimed supplied the correct IFU to IsoTis so that they could perform a field correction of the affected product. October 1, 2006 IsoTis OrthoBiologics sent their consignees a recall notification that included the IsoTis notification letter, a copy of the Teknimed recall letter, IsoTis Field Correction Instruction Sheet and replacement TCP IFU's for the affected lots.

    Distribution

    Nationwide

    Quantity

    1681 units