BEUDAMED
    FDA Recall Terminated

    AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender.

    Recall: Z-1562-2014 · Initiated March 25, 2014

    Recall

    Recall Number
    Z-1562-2014
    Event Number
    67986
    Firm
    AlloSource, Inc.
    FEI Number
    3000215346
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 25, 2014
    Posted
    May 6, 2014
    Terminated
    August 11, 2014
    Address
    6278 S Troy Cir, Centennial, CO, 80111-6422

    Description

    AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender.

    Reason

    The donor was hemodiluted.

    Action

    AlloSource sent letter via USPS Certified Mail Receipt to all affected customers dated March 25, 2014, and March 26, 2014. The letter identified the product the problem and the action needed to be taken by the customer. AlloSource requested that the distributor consignee notify subsequent consignees to determine disposition and to request return of unused product. Returned inventory will be quarantined physically and electronically upon receipt. Product initially quarantined and product returned will be destroyed following established procedures. Further questions please call (720) 873-4733

    Distribution

    Distribution US nationwide, including Michigan and a distributor in Colorado.

    Quantity

    29