Reported Aug 14, 2013 · Terminated
Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical…
SpineFrontier, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SpineFrontier, Inc. · 500 Cummings Ctr Ste 3500 · Beverly, MA · 01915-6516
Is this the product you have?
- 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.
- Lot codes and dates
- Lot/Serial Numbers
027104027105
- Lot/Serial Numbers
- Amount recalled
- 12 devices
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Device design.
This product could cause temporary or reversible health problems — stop using it.
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