BEUDAMED
    FDA Recall Terminated

    SYNTHES BENDING PLIERS - STRAIGHT FOR CRANIOFACIAL/ORTHOGNATHIC PL, Catalog # SD347.967. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surgery.

    Recall: Z-0076-2010 · Initiated September 3, 2009

    Recall

    Recall Number
    Z-0076-2010
    Event Number
    53327
    Firm
    Synthes USA (HQ), Inc.
    FEI Number
    3005180112
    Product Code
    HTC
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    September 3, 2009
    Posted
    October 26, 2009
    Terminated
    March 8, 2010
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    SYNTHES BENDING PLIERS - STRAIGHT FOR CRANIOFACIAL/ORTHOGNATHIC PL, Catalog # SD347.967. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surgery.

    Reason

    The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.

    Action

    The customer account was notified by an Urgent: Medical Device Removal letter via USPS certified mail on 9/4/2009. The letter stated that the products did not have clearance for the hospital's intended use and that if the customer has any of the identified devices, they should call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Also, the customer should complete the Verification Section, and return the letter along with any remaining product. For questions the hospital could call 610-719-5865.

    Distribution

    Nationwide Distribution -- State of CA.

    Quantity

    4