Recall Z-0222-2016— Stryker Spine

Name: FDA recall Z-0222-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-08

Class II · Terminated

Class II FDA medical device recall by Stryker Spine, initiated 2015-09-08, terminated 2019-01-14. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm: Stryker Spine
Classification: Class II
Status: Terminated
Initiated: 2015-09-08
Terminated: 2019-01-14
Firm location: Allendale, NJ, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.