216 Wilson Frame Pads — Class II medical device recall Z-1867-2017
Terminated recall by Mizuho OSI, reported 2017-04-26. Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their
| Recall number | Z-1867-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mizuho OSI, Union City, CA, United States |
| Recall initiated | 2017-03-28 |
| Classified | 2017-04-19 |
| Reported by FDA | 2017-04-26 |
| Terminated | 2017-08-15 |
| Countries outside the US | AU, CA, CH, DE, ES, GB, HK, JP, KE, KR, NZ, SA, SE |
| Quantity | 216 sets |
| UPC / GTIN / UDI-DI | 00842430100192 |
| Model numbers | 5319-37, 5319G, 5321G |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1867-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.