FDA-Device2015-11-11Class II
Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
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.
Sold states
Nationwide Distribution.
Affected count
41 units
Manufactured in
2 Pearl Ct, N/A, Allendale, NJ, United States
Products
Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0222-2016Don't want to check this manually?
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