BEUDAMED
    FDA Recall Terminated

    Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone.

    Recall: Z-0092-2013 · Initiated April 20, 2012

    Recall

    Recall Number
    Z-0092-2013
    Event Number
    62569
    Firm
    Osteotech Inc
    FEI Number
    3002600221
    Product Code
    MBP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 20, 2012
    Posted
    October 18, 2012
    Terminated
    January 17, 2014
    Address
    51 James Way, Eatontown, NJ, 07724-2272

    Description

    Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone.

    Reason

    Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.

    Action

    Osteotech sent out recall letters/questionairres dated April 20, 2012, to Risk Managers/service representatives. The recall was expanded on August 1 2012. The letter identified the product, the problem, and the action to be taken by the customer. Sales Representatives would facillitate the return of any affected product they may have or provide cautionary labels for any affected product and/or support in the completion of the attached questionnaire. Customers were asked to disseminate this information to additional personnel within their facility as appropriate and return the questionnaire to Medtronic.. Customers with questions should contact their Medtronic Sales Representative at 800-876-3133, extension 3197. For questions regarding this recall call 732-542-2800. Osteotech sent an additional letter stating that The OPTIUMTM (DBM) product line was added in error.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally.

    Quantity

    9,533 units