BEUDAMED
    FDA Enforcement Class II Terminated

    Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration.

    Recall: Z-2076-2014 · Reported July 23, 2014

    Enforcement

    Recall Number
    Z-2076-2014
    Event ID
    68619
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PIONEER SURGICAL TECHNOLOGY, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 23, 2014
    Initiation Date
    June 11, 2014
    Classification Date
    July 17, 2014
    Termination Date
    October 22, 2014
    Address
    375 River Park Cir, N/A, Marquette, MI, 49855-1781, United States

    Description

    Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration.

    Reason

    Lack of Sterility Assurance

    Code Info

    Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018

    Distribution

    US Nationwide Distribution in the states of TX and FL

    Quantity

    5