BEUDAMED
    FDA Recall Terminated

    Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits: Product Codes: KRYP-US-Z-05 (5cc Kit) KRYP-US-Z -10 (10cc Kit) Product Usage: Kryptonite Bone Cement is a resinous material indicated for use in repairing cranial defects

    Recall: Z-1496-2012 · Initiated April 6, 2012

    Recall

    Recall Number
    Z-1496-2012
    Event Number
    61709
    Firm
    Doctor's Research Group, Inc.
    FEI Number
    3002522629
    Product Code
    GXP
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 6, 2012
    Posted
    May 8, 2012
    Terminated
    July 14, 2015
    Address
    574 Heritage Rd, Southbury, CT, 06488-1868

    Description

    Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits: Product Codes: KRYP-US-Z-05 (5cc Kit) KRYP-US-Z -10 (10cc Kit) Product Usage: Kryptonite Bone Cement is a resinous material indicated for use in repairing cranial defects

    Reason

    Bone cement strength and stiffness fall below specification at body temperature

    Action

    Doctors Research Group (DRG) issued a Voluntary Product Recall Notification letter dated April 2012 to all affected customers via email or Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were instructed to identify, segregate and return any affected products in their possession. Customers were asked to fill out and return the enclosed verification form Distributors were requested to notify their customers. For questions contact DRG at 203-262-9335.

    Distribution

    USA Nationwide Distribution

    Quantity

    3100 kits