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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 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position. Lot/Serial Number: IM71013-01: Lot 0000 Class II Mismarked and unmarked screws Z-0576-2014
Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position. Lot/Serial Number: IM71 0 16-01: Lots 0000, 000 1 Class II Mismarked and unmarked screws Z-0575-2014
Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position. Lot/Serial Number: IM71 059-01: Lot 0000 lM71059-02; IM71059-02: Lot 035M Class II Mismarked and unmarked screws 922 Z-0574-2014
Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position. Lot/Serial Number: IM71058-0l: Lot 0000; IM71058-02: Lot 0000; IM71058-03 : Lot 0000 Class II Mismarked and unmarked screws 993 Z-0573-2014
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