Mizuho Wilson Frame Pads Recalled for Potential Pressure Injury Risk
Mizuho OSI is recalling 216 Wilson Frame Pads due to a design deficiency that may allow patients to contact the frame's carbon fiber structure, potentially causing pressure injuries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (pressure injury) where injury has not yet been reported, fitting the criteria for a High severity score (3).
Plain-English summary
Mizuho OSI is recalling 216 sets of Wilson Frame Pads, Model # 5319-37. These pads are used with Radiolucent Wilson Frames (models 5319G and 5321G) to support the torso of prone patients during spine surgery. The affected units were manufactured between December 2016 and March 2017 and were distributed in the United States, Canada, Japan, Australia, New Zealand, Great Britain, Sweden, Spain, Germany, Switzerland, Kenya, Saudi Arabia, Hong Kong, and South Korea.
The recall is due to a design deficiency in the construction of the mounting sleeves. This defect may allow the patient to come into direct contact with the underlying carbon fiber structure of the Wilson frame, which could lead to a pressure injury. The agency has classified this as a Class II recall.
Healthcare facilities and users should stop using the affected pads immediately. Mizuho OSI is the recalling firm responsible for managing the recall. No specific instructions for consumers are provided in the source text, but medical professionals should verify if they possess these specific model numbers and manufacturing dates.
The recalled product
- 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 su
- Manufacturer
- Mizuho OSI
- Affected units
- 216
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All Lots: Manufacturing dates: December 2016 through March 2017
- GTIN:00842430100192
Distribution
Distribution scope not specified by the agency.
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