BEUDAMED
    FDA Recall Terminated

    OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right

    Recall: Z-1382-2017 · Initiated January 25, 2017

    Recall

    Recall Number
    Z-1382-2017
    Event Number
    76356
    Firm
    Matrix Surgical Holdings, LLC
    FEI Number
    3009383407
    Product Code
    KKY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 25, 2017
    Posted
    February 28, 2017
    Terminated
    May 24, 2017
    Address
    4025 Welcome All Rd Sw, Ste 120, Atlanta, GA, 30349-1876

    Description

    OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right

    Reason

    Mislabeling. The packaging labeled as left mandible contained a right mandible.

    Action

    Matrix Surgical sent an Urgent Product Recall e-mail dated January 26, 2017, to the foreign consignees. The distributors were instructed to return the product in inventory, and to conduct a sub-recall, if needed. For further questions, please call ( 404) 862-3794.

    Distribution

    Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan

    Quantity

    28