Z-0222-2016 Class II Terminated
FDA device recall Z-0222-2016 was initiated by Stryker Spine on September 8, 2015 and is designated Class II. 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. The recall status is terminated (terminated January 14, 2019). Affected quantity: 41 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 11, 2015
- Initiation Date
- September 8, 2015
- Termination Date
- January 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 units
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.
Distribution Pattern
Nationwide Distribution.
Code Information
Reference Number 48590100 Lots B40155, B34446, B34447 and B41171.