FDA-Device2017-04-26Class II
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.
Mizuho OSI
Hazard
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.
Sold states
United States, Canada, Japan, Australia, New Zealand, Great Britain, Sweden, Spain, Germany, Switzerland, Kenya, Saudi Arabia, Hong Kong, South Korea.
Affected count
216 sets
Manufactured in
30031 Ahern Ave, N/A, Union City, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1867-2017Don't want to check this manually?
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