BEUDAMED
    FDA Enforcement Class II Terminated

    Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.

    Recall: Z-2965-2018 · Reported September 12, 2018

    Enforcement

    Recall Number
    Z-2965-2018
    Event ID
    80731
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 12, 2018
    Initiation Date
    July 12, 2018
    Classification Date
    August 31, 2018
    Termination Date
    May 1, 2020
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.

    Reason

    A size 22mm threaded peg was found in the package of a 10mm unit.

    Code Info

    Lot 969440; UDI (01)00887868012310(17)280309(10)969440

    Distribution

    International Distribution to countries of: Japan and Netherlands.

    Quantity

    25 units