Stryker UniVise Spinous Process Fixation Plate System Inserter — Class II medical device recall Z-0222-2016
Terminated recall by Stryker Spine, reported 2015-11-11, distributed nationwide. The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the
| Recall number | Z-0222-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Spine, Allendale, NJ, United States |
| Recall initiated | 2015-09-08 |
| Classified | 2015-11-05 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2019-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 41 units |
| Lot numbers | B34446, B34447, B40155, B41171 |
Product
Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
Reason for recall
The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.
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-0222-2016. 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.