BEUDAMED
    FDA Enforcement Class II Terminated

    Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors.

    Recall: Z-0803-2015 · Reported December 24, 2014

    Enforcement

    Recall Number
    Z-0803-2015
    Event ID
    69784
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Spine
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 24, 2014
    Initiation Date
    October 6, 2014
    Classification Date
    December 15, 2014
    Termination Date
    May 8, 2017
    Address
    2 Pearl Ct, N/A, Allendale, NJ, 07401-1611, United States

    Description

    Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors.

    Reason

    Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery.

    Code Info

    Lot number 4279

    Distribution

    Distributed to GA, IN, MI, NJ, OH, PA, TX & VA.

    Quantity

    15 units