BEUDAMED
    FDA Recall 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 · Initiated March 28, 2017

    Recall

    Recall Number
    Z-1867-2017
    Event Number
    76920
    Firm
    Mizuho OSI
    FEI Number
    2921578
    Product Code
    FWZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 28, 2017
    Posted
    April 19, 2017
    Terminated
    August 15, 2017
    Address
    30031 Ahern Ave, Union City, CA, 94587-1234

    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.

    Action

    Letters were sent to customers and distributors on March 28, 2017 by Federal Express or UPS. Information is also posted on firm's web site. Frames having 5319-37 pads should not be used and all of the affected pads retrieved and destroyed.

    Distribution

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

    Quantity

    216 sets