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Mizuho OSI recalls 216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. Genera
Recalled April 26, 2017 · FDA recall Z-1867-2017 · 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. · FDA Class II
Units
216 sets
Sold at
United States, Canada, Japan, Australia, New Zealand, Great Britain, Sweden, Spain, Germany, Switzerland, Kenya, Saudi Arabia, Hong Kong, South Korea.
Description
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.
Product
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(s)
Mizuho OSI
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →