BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

    Recall: Z-2099-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2099-2013
    Event ID
    65891
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    July 8, 2013
    Classification Date
    August 27, 2013
    Termination Date
    March 31, 2015
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002, United States

    Description

    Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

    Reason

    Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect.

    Code Info

    Catalog # 604640, Lot Code R11428 21 units Catalog # 604642S, Lot Code R09071 1 unit

    Distribution

    USA Nationwide Distribution in the states of: FL. OH, TX, & VA

    Quantity

    23 units