BEUDAMED
    FDA Recall 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 · Initiated October 6, 2014

    Recall

    Recall Number
    Z-0803-2015
    Event Number
    69784
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 6, 2014
    Posted
    December 16, 2014
    Terminated
    May 8, 2017
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    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.

    Action

    Stryker Spine sent an Urgent Medical Device Removal Notification/Acknowledgement Form dated 10/6/2014 via Fed Ex. The letter identified the affected product, discussed the product description, product issue, potential hazards, risk mitigations, and actions needed. Customers were asked to read the notice thoroughly and make sure that it is understood. Additionally, they are to complete the enclosed acknowledgement form and fax or e-mail it back.

    Distribution

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

    Quantity

    15 units