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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Event Detail

Event ID 65444
Product Type Devices
Status Ongoing
Recalling Firm SpineFrontier, Inc.
City Beverly
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-10
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including Texas, Ohio, and Missouri.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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/Serial Numbers: 027104, 027105 Class II Device design. 12 devices Z-1927-2013