Z-1867-2017 Class II Terminated
FDA device recall Z-1867-2017 was initiated by Mizuho OSI on March 28, 2017 and is designated Class II. 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 struct… The recall status is terminated (terminated August 15, 2017). Affected quantity: 216 sets.
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2017
- Initiation Date
- March 28, 2017
- Termination Date
- August 15, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 216 sets
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.
Distribution Pattern
United States, Canada, Japan, Australia, New Zealand, Great Britain, Sweden, Spain, Germany, Switzerland, Kenya, Saudi Arabia, Hong Kong, South Korea.
Code Information
All Lots: Manufacturing dates: December 2016 through March 2017; GTIN:00842430100192