Device product
Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
Z-0222-2016
Product summary
- Firm
- Stryker Spine
- Event
- Event 72495
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41 units
- Official record key
device-enforcement:Z-0222-2016
Official wording
Reason: The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.
Code information: Reference Number 48590100 Lots B40155, B34446, B34447 and B41171.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.