FDA Device recall Z-0222-2016
Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile
- FDA Device
- Class II
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class II recall of Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile by Stryker Spine, citing the Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0222-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-08 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Spine |
| Distribution | US |
Product
Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
Reason
The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.
Identifiers
| code_info | Reference Number 48590100 Lots B40155, B34446, B34447 and B41171. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0222-2016%22
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