BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1382-2017 · Reported March 8, 2017

    Enforcement

    Recall Number
    Z-1382-2017
    Event ID
    76356
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Matrix Surgical Holdings, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 8, 2017
    Initiation Date
    January 25, 2017
    Classification Date
    February 28, 2017
    Termination Date
    May 24, 2017
    Address
    4025 Welcome All Rd Sw Ste 120, N/A, Atlanta, GA, 30349-1876, United States

    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.

    Code Info

    OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816)

    Distribution

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

    Quantity

    28