FDA Device recall Z-1867-2017
216 Wilson Frame Pads, Model # 5319-37
- FDA Device
- Class II
- terminated
- Published 2017-04-26
On 2017-04-26 the FDA classified a Class II recall of 216 Wilson Frame Pads, Model # 5319-37 by Mizuho Osi, citing 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 underlyin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1867-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-28 |
| Published | 2017-04-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mizuho Osi |
| Distribution | n/a |
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.
Reason
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.
Identifiers
| code_info | All Lots: Manufacturing dates: December 2016 through March 2017; GTIN:00842430100192 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1867-2017%22
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