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Stryker Spine recalls Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100.
Recalled November 11, 2015 · FDA recall Z-0222-2016 · Stryker Spine
Hazard
The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized. · FDA Class II
Units
41 units
Sold at
Nationwide Distribution.
Description
The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.
Product
Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
Manufacturer(s)
Stryker Spine
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →