Mizuho OSI: Medical Device Recall in 2017 - (Recall #: Z-1867-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 28, 2017

Date Posted: April 26, 2017

Recall Number: Z-1867-2017

Event ID: 76920

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.

Status: Terminated

Product Quantity: 216 sets

Code Information:

All Lots: Manufacturing dates: December 2016 through March 2017; GTIN:00842430100192

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated