Home / Recalls / SpineFrontier, Inc. / Z-0576-2014

Z-0576-2014 Class II Terminated

Recalled by SpineFrontier, Inc. — Beverly, MA

FDA device recall Z-0576-2014 was initiated by SpineFrontier, Inc. on Nov 20, 2013 and is designated Class II. Reason for recall: Mismarked and unmarked screws The recall status is terminated (terminated Sep 6, 2018).

Recall details

Product Type: Devices
Report Date: Jan 1, 2014
Initiation Date: Nov 20, 2013
Termination Date: Sep 6, 2018
Voluntary/Mandated: Voluntary: Firm initiated

Product description

Indus Invue Screws: IM71013-XX: Indus Screw04.0mm 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: IM71013-01: Lot 0000

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0576-2014
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by SpineFrontier, Inc.

Z-1973-2019 Class II — A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part… (Jun 13, 2019)
Z-1479-2015 Class II — SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique… (Mar 5, 2015)
Z-0977-2015 Class II — lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164 (Dec 19, 2014)
Z-0574-2014 Class II — Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to… (Nov 20, 2013)
Z-0555-2014 Class II — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113… (Nov 20, 2013)
Z-0554-2014 Class II — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part#… (Nov 20, 2013)
Z-0573-2014 Class II — Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure… (Nov 20, 2013)
Z-0553-2014 Class II — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110… (Nov 20, 2013)
Z-0575-2014 Class II — Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue… (Nov 20, 2013)
Z-0544-2014 Class II — PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw… (Oct 18, 2013)