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Recall Observatory FDA recall evidence

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

May 10, 2013

Class II

Product summary

Firm
SpineFrontier, Inc.
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

    reason.no_named_rule · v1.0.0

    Device design.