BEUDAMED
    FDA Enforcement Class II 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 · Reported May 14, 2014

    Enforcement

    Recall Number
    Z-1562-2014
    Event ID
    67986
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AlloSource, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 14, 2014
    Initiation Date
    March 25, 2014
    Classification Date
    May 6, 2014
    Termination Date
    August 11, 2014
    Address
    6278 S Troy Cir, N/A, Centennial, CO, 80111-6422, United States

    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.

    Code Info

    Lot numbers 132095-603, 608, 609, 611-618, 622-629, 631-634, and 636-638. Lot numbers 132095-604, 619, and 621.

    Distribution

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

    Quantity

    29