BEUDAMED
    FDA Recall Terminated

    Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating System, and the Matrix MANDIBLE Plating System.

    Recall: Z-0973-2015 · Initiated December 15, 2014

    Recall

    Recall Number
    Z-0973-2015
    Event Number
    70018
    Firm
    Synthes, Inc.
    FEI Number
    3005180112
    Product Code
    GAD
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 15, 2014
    Posted
    January 14, 2015
    Terminated
    August 18, 2016
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating System, and the Matrix MANDIBLE Plating System.

    Reason

    Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured from an incorrect material. Surgical delay may occur. Spring particles could transfer from the instrument to the patient, and may lead to an adverse tissue reaction and/or infection.

    Action

    The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated December 15, 2014, to its end users and sales consultants. The letter identified the product, problem, and actions to be taken. The End users/sales staff were instructed to immediately remove affected stock from inventory; call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number; complete and return the attached Verification Section to DePuy Synthes via fax: 866-827-3421 or Scan/email: [email protected], even if you do not have any of the affected product, and return any affected devices to Synthes. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes sales consultant.

    Distribution

    Worldwide Distribution: US (nationwide) and internationally to Canada.

    Quantity

    1762