BEUDAMED
    FDA Recall Terminated

    SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) The implant holder is used to place the implant into the vertebral disc space.

    Recall: Z-2583-2010 · Initiated July 23, 2010

    Recall

    Recall Number
    Z-2583-2010
    Event Number
    56343
    Firm
    Synthes USA (HQ), Inc.
    FEI Number
    3005180112
    Product Code
    MQP
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    July 23, 2010
    Terminated
    December 18, 2014
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) The implant holder is used to place the implant into the vertebral disc space.

    Reason

    A potential for the implant holder tip to break off and lodge in the SynFix-LR implant, which pose a potential risk to the patient.

    Action

    Synthes Spine Hospital sent an ' URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated August 20, 2010 to all customers. The letter described the labeling issue and actions to be taken by the customers. The customers were instructed to review the supplementary labeling provided; contact their Synthes Spine Sales Consultant to arrange for provision of the Holding Forceps (p/n 388.401) prior to each SynFix-LR procedure; and complete and return the enclosed Verification Section form to Synthes via fax at 610-251-9005 or email: [email protected]. If you have any questions, please call 1-800-620-7025 x 3500 or contact your Synthes Spine Sales Consultant.

    Distribution

    Worldwide Distribution: USA and the countries of Canada, Japan, Switzerland, Australia, Mexico, Malaysia, New Zealand, and Singapore.