Recall Z-1867-2017— Mizuho OSI
Class II · Terminated
Class II FDA medical device recall by Mizuho OSI, initiated 2017-03-28, terminated 2017-08-15. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Mizuho OSI
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-28
- Terminated
- 2017-08-15
- Firm location
- Union City, CA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.