Z-1867-2017 Class II Terminated
FDA device recall Z-1867-2017 was initiated by Mizuho OSI on Mar 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… The recall status is terminated (terminated Aug 15, 2017). Affected quantity: 216 sets.
Recall details
- Product Type
- Devices
- Report Date
- Apr 26, 2017
- Initiation Date
- Mar 28, 2017
- Termination Date
- Aug 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1867-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026