FDAMarch 28, 2017device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
mizuho osimizuho
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAHANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-1442021-07-29
- FDAMizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.2021-02-08
- USDA FSISOSI Industries, LLC Recalls Ready-To-Eat Beef Patty Products Due to Possible Foreign Matter Contamination2019-10-28
- FDALevo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.2019-10-14
- FDAMicrosurgical Operating Room Tables;7300BX (18-351-70).2019-09-11
- FDAMicrosurgical Operating Room Tables;7300B (18-350-70);2019-09-11
- USDA FSISOSI Industries, LLC Recalls Chicken Products Due To Possible Foreign Matter Contamination2016-11-06
- FDAMizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or late...2015-12-14
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