FDAFDA · Food and drugs·Recall number Z-1867-2017
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.
Published April 26, 2017 · Recall initiated: March 28, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mizuho OSI
- Distributor
- United States, Canada, Japan, Australia, New Zealand, Great Britain, Sweden, Spain, Germany, Switzerland, Kenya, Saudi Arabia, Hong Kong, South Korea.
- Lot
- All Lots: Manufacturing dates: December 2016 through March 2017; GTIN:00842430100192
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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