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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 Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
Recall Number Z-0574-2014
Classification Class II
Code Info Lot/Serial Number: IM71 059-01: Lot 0000 lM71059-02; IM71059-02: Lot 035M
Product Distributed Qty 922
Reason For Recall Mismarked and unmarked screws

Event Detail

Event Id 66914
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 Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
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