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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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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. .

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 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. VM13222- 34489 Class II Screw inserters may not mate properly with hex interface of the screws. 13 Z-0555-2014
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. VM 13194-34457 Class II Screw inserters may not mate properly with hex interface of the screws. 25 Z-0554-2014
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 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. VM13221-34457 Class II Screw inserters may not mate properly with hex interface of the screws. 4 Z-0553-2014
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