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.
This recall has been terminated (originally issued April 19, 2017).
- Company
- Mizuho Osi
- Recall Initiated
- March 28, 2017
- Posted
- April 19, 2017
- Terminated
- August 15, 2017
- Recall Number
- Z-1867-2017
- Quantity
- 216 sets
- Firm Location
- Union City, CA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
All Lots: Manufacturing dates: December 2016 through March 2017; GTIN:00842430100192
Root Cause
Process control
Action Taken
Letters were sent to customers and distributors on March 28, 2017 by Federal Express or UPS. Information is also posted on firm's web site. Frames having 5319-37 pads should not be used and all of the affected pads retrieved and destroyed.