BEUDAMED
    FDA Recall Terminated

    Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adults and children.

    Recall: Z-2272-2015 · Initiated June 24, 2015

    Recall

    Recall Number
    Z-2272-2015
    Event Number
    71595
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    JEY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 24, 2015
    Posted
    July 28, 2015
    Terminated
    August 18, 2016
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adults and children.

    Reason

    The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation.

    Action

    DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated June 24, 2015, to all affected customers. Customers were asked to check their inventory and return affected devices with the completed response form. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant.

    Distribution

    Nationwide Distribution including CA, UT, CO, NJ, WA, VT, KY, WY, CT, NY, MS, and MD.

    Quantity

    31