BEUDAMED
    FDA Enforcement Class II Terminated

    LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401. Provides access to the thoracic and lumbar spine from a posterior approach via a small incision.

    Recall: Z-2155-2012 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2155-2012
    Event ID
    62648
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Spine
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2012
    Initiation Date
    April 23, 2012
    Classification Date
    August 7, 2012
    Termination Date
    November 13, 2013
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611, United States

    Description

    LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401. Provides access to the thoracic and lumbar spine from a posterior approach via a small incision.

    Reason

    Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu.

    Code Info

    Lot Code: 093309

    Distribution

    Worldwide Distribution -- US, Switzerland, Netherlands, Brazil, Hong Kong, Germany, and Taiwan.

    Quantity

    30 devices