Reported Apr 26, 2017 · Terminated
216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and…
Mizuho OSI
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mizuho OSI · 30031 Ahern Ave · Union City, CA · 94587-1234
Is this the product you have?
216 Wilson Frame PadsModel # 5319-37Used with Radiolucent Wilson Framesmodel numbers 5319G and 5321G
- General and Plastic SurgeryThese 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
- Lot codes and dates
- All LotsManufacturing
- datesDecember 2016 through March 2017
- GTIN00842430100192
- Amount recalled
- 216 sets
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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