BEUDAMED
    FDA Enforcement Class II Terminated

    smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.

    Recall: Z-0408-2018 · Reported January 31, 2018

    Enforcement

    Recall Number
    Z-0408-2018
    Event ID
    78672
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 31, 2018
    Initiation Date
    November 29, 2017
    Classification Date
    January 24, 2018
    Termination Date
    September 1, 2020
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.

    Reason

    One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.

    Code Info

    17AM14602

    Distribution

    US Distribution to the state of OR, and Internationally to Colombia.

    Quantity

    12