216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and

FDA device recall Z-1867-2017 · posted 2017-04-19 · Terminated

Recall details

Recalling firm

Mizuho OSI

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.

Action taken

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

Status

Terminated

Product code

FWZ

Quantity affected

216 sets

Distribution

United States, Canada, Japan, Australia, New Zealand, Great Britain, Sweden, Spain, Germany, Switzerland, Kenya, Saudi Arabia, Hong Kong, South Korea.

Date initiated

2017-03-28

Date posted

2017-04-19

Date terminated

2017-08-15

Location

Union City, CA