BEUDAMED
    FDA Enforcement Class II Terminated

    Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation

    Recall: Z-2111-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2111-2017
    Event ID
    77262
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2017
    Initiation Date
    May 11, 2017
    Classification Date
    May 18, 2017
    Termination Date
    November 3, 2017
    Address
    Sulzer Allee 8, Winterthur, N/A, Switzerland

    Description

    Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation

    Reason

    the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.

    Code Info

    Lots: 13065 13569 13571

    Distribution

    Single US consignee CO.

    Quantity

    138 (OUS 297)