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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Product Detail

Product Description PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
Recall Number Z-0554-2014
Classification Class II
Code Info VM 13194-34457
Product Distributed Qty 25
Reason For Recall Screw inserters may not mate properly with hex interface of the screws.

Event Detail

Event Id 66873
Product Type Devices
Status Ongoing
Recalling Firm SpineFrontier, Inc.
City Beverly
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .