BEUDAMED
    FDA Enforcement Class II Terminated

    6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured where beneficial to the application, and they are secured to the bone with 3.5mm non-locking screws. The Acumed pelvic ring plate is the Pubic Symphysis Plate. The Acumed Pelvic Plating System is intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fixation. The device is to be implanted by the surgeon in a sterile operating room setting.

    Recall: Z-1199-2017 · Reported February 22, 2017

    Enforcement

    Recall Number
    Z-1199-2017
    Event ID
    76332
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Acumed LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 22, 2017
    Initiation Date
    January 19, 2017
    Classification Date
    February 14, 2017
    Termination Date
    May 8, 2017
    Address
    5885 NW Cornelius Pass Rd, N/A, Hillsboro, OR, 97124-9432, United States

    Description

    6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured where beneficial to the application, and they are secured to the bone with 3.5mm non-locking screws. The Acumed pelvic ring plate is the Pubic Symphysis Plate. The Acumed Pelvic Plating System is intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fixation. The device is to be implanted by the surgeon in a sterile operating room setting.

    Reason

    The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V ELI per ASTM F135  Ti alloy) and was distributed.

    Code Info

    Lot number: 383813

    Distribution

    Worldwide Distribution - Costa Rica, Malaysia, Mexico, South Africa, and Spain

    Quantity

    15 units