Events

Recall of Device Recall 216 Wilson Frame Pads, Model 531937

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mizuho OSI.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76920
  • Event Risk Class
    Class 2
  • Event Number
    Z-1867-2017
  • Event Initiated Date
    2017-03-28
  • Event Date Posted
    2017-04-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154562
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Operating Room Accessories Table Tray - Product Code FWZ
  • 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.

Device

Device Recall 216 Wilson Frame Pads, Model 531937
  • Model / Serial
    All Lots: Manufacturing dates: December 2016 through March 2017; GTIN:00842430100192
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    United States, Canada, Japan, Australia, New Zealand, Great Britain, Sweden, Spain, Germany, Switzerland, Kenya, Saudi Arabia, Hong Kong, South Korea.
  • Product 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.
  • Manufacturer
    Mizuho OSI

Manufacturer

Mizuho OSI
  • Manufacturer Address
    Mizuho OSI, 30031 Ahern Ave, Union City CA 94587-1234
  • Source
    USFDA