Device product
Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.
Z-1927-2013
Product summary
- Event
- Event 65444
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 devices
- Official record key
device-enforcement:Z-1927-2013
Official wording
Reason: Device design.
Code information: Lot/Serial Numbers: 027104, 027105
Distribution pattern: Nationwide Distribution including Texas, Ohio, and Missouri.
Derived failure modes
-
Unknown
Device design.