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
Check against the official notice below — it lists the full affected range.
Mizuho OSI has recalled 216 sets of model 5319-37 Wilson Frame Pads used with Radiolucent Wilson Frames (models 5319G and 5321G) in general and plastic surgery procedures. The pads have a design deficiency in their mounting sleeves that may allow patients to contact the underlying carbon fiber structure of the Wilson frame, potentially causing pressure injuries. The affected pads 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 source document does not specify what remedy affected consumers should pursue.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: United States, Canada, Japan, Australia, New Zealand, Great Britain, Sweden, Spain, Germany, Switzerland, Kenya, Saudi Arabia, Hong Kong, South Korea. Quantity: 216 sets Lot/code info: All Lots: Manufacturing dates: December 2016 through March 2017; GTIN:00842430100192
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.