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.
FDA Recall Z-1867-2017 · Posted 2017-04-19
Advertisement
Recalling FirmMizuho OSI
Recall StatusTerminated
Product CodeFWZ
Date Initiated2017-03-28
Date Terminated2017-08-15
Product Quantity216 sets
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
United States, Canada, Japan, Australia, New Zealand, Great Britain, Sweden, Spain, Germany, Switzerland, Kenya, Saudi Arabia, Hong Kong, South Korea.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement