BEUDAMED
    FDA Enforcement Class II Terminated

    smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

    Recall: Z-2163-2018 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2163-2018
    Event ID
    80125
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 20, 2018
    Initiation Date
    May 4, 2018
    Classification Date
    June 11, 2018
    Termination Date
    February 22, 2019
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

    Reason

    One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.

    Code Info

    15FM16181

    Distribution

    International only: United Arab Emirates, Spain, Mexico

    Quantity

    5 units