Home / Recalls / SpineFrontier, Inc. / Z-0574-2014

Z-0574-2014 Class II Terminated

Recalled by SpineFrontier, Inc. — Beverly, MA

Recall Details

Product Type
Devices
Report Date
January 1, 2014
Initiation Date
November 20, 2013
Termination Date
September 6, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
922

Product Description

Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.

Reason for Recall

Mismarked and unmarked screws

Distribution Pattern

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

Code Information

Lot/Serial Number: IM71 059-01: Lot 0000 lM71059-02; IM71059-02: Lot 035M

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  • Z-0553-2014 Class II — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 (November 20, 2013)
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  • Z-0555-2014 Class II — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 (November 20, 2013)
  • Z-0554-2014 Class II — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-8011 (November 20, 2013)
  • Z-0573-2014 Class II — Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure (November 20, 2013)
  • Z-0544-2014 Class II — PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw impla (October 18, 2013)