BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached.

    Recall: Z-0381-2013 · Reported November 28, 2012

    Enforcement

    Recall Number
    Z-0381-2013
    Event ID
    63386
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Spine
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2012
    Initiation Date
    August 9, 2012
    Classification Date
    November 19, 2012
    Termination Date
    September 30, 2015
    Address
    2 Pearl Ct, N/A, Allendale, NJ, 07401-1611, United States

    Description

    Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached.

    Reason

    Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.

    Code Info

    Class I device, 510(K) exempt Catalog Number: 48287028 Lot Number: 098400

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.

    Quantity

    19 units