BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set

    Recall: Z-2265-2014 · Reported August 27, 2014

    Enforcement

    Recall Number
    Z-2265-2014
    Event ID
    68738
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 27, 2014
    Initiation Date
    June 30, 2014
    Classification Date
    August 18, 2014
    Termination Date
    December 18, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set

    Reason

    A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.

    Code Info

    Part Number: 145.17E Lot Number: EV01609, individual part numbers contained within 145.17E: 304.49 309.501 310.221 310.804 311.43 312.151 312.153 313.969 314.463 314.464 314.465 319.291 319.292 319.702 319.97 398.408 398.409 402.608-402.640 402.714-402.740 419.89 419.972 292.622, and 292.623.

    Distribution

    Distributed in the states of WI and MI.

    Quantity

    4