BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP).

    Recall: Z-1681-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1681-2014
    Event ID
    68006
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 11, 2014
    Initiation Date
    April 8, 2014
    Classification Date
    June 2, 2014
    Termination Date
    September 10, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP).

    Reason

    Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.

    Code Info

    Product no. 03.807.507, lot no. 8029684, and product no. 03.807.508, lot no. 8029689.

    Distribution

    US Distribution including the states of FL, NJ and MN.

    Quantity

    3