Z-1867-2017Class II

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

Name: Z-1867-2017 216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G...
Creator: Mizuho OSI
Published: 2017-03-28
License: https://open.fda.gov/license/

Mizuho Orthopedic Systems Inc / initiated 2017-03-28 / Terminated / root cause: manufacturing process

FDA source

Mizuho OSI began a recall of 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... on 2017-03-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1867-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-28
Posted: 2017-04-19
Terminated: 2017-08-15
Recalling firm: Mizuho Orthopedic Systems Inc
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.
Product code: FWZ Operating Room Accessories Table Tray
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: All Lots: Manufacturing dates: December 2016 through March 2017; GTIN:00842430100192

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1867-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1867-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-19

Product code FWZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)