BEUDAMED
    FDA Enforcement Class II Terminated

    216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.

    Recall: Z-1867-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1867-2017
    Event ID
    76920
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mizuho OSI
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 26, 2017
    Initiation Date
    March 28, 2017
    Classification Date
    April 19, 2017
    Termination Date
    August 15, 2017
    Address
    30031 Ahern Ave, N/A, Union City, CA, 94587-1234, United States

    Description

    216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.

    Reason

    Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their mounting sleeves that may allow the patient to contact the underlying carbon fiber structure of the Wilson frame and could lead to a pressure injury.

    Code Info

    All Lots: Manufacturing dates: December 2016 through March 2017; GTIN:00842430100192

    Distribution

    United States, Canada, Japan, Australia, New Zealand, Great Britain, Sweden, Spain, Germany, Switzerland, Kenya, Saudi Arabia, Hong Kong, South Korea.

    Quantity

    216 sets