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U.S. Department of Health and Human Services

Class 2 Device Recall 216 Wilson Frame Pads, Model 531937

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  Class 2 Device Recall 216 Wilson Frame Pads, Model 531937 see related information
Date Initiated by Firm March 28, 2017
Date Posted April 19, 2017
Recall Status1 Terminated 3 on August 15, 2017
Recall Number Z-1867-2017
Recall Event ID 76920
Product Classification Operating Room Accessories Table Tray - Product Code FWZ
Product 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.
Code Information All Lots: Manufacturing dates: December 2016 through March 2017; GTIN:00842430100192
Recalling Firm/
Manufacturer		 Mizuho OSI
30031 Ahern Ave
Union City CA 94587-1234
For Additional Information Contact Gina Costelli
800-777-4674
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 216 sets
Distribution United States, Canada, Japan, Australia, New Zealand, Great Britain, Sweden, Spain, Germany, Switzerland, Kenya, Saudi Arabia, Hong Kong, South Korea.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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