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

Z-0574-2014 Class II Terminated

Recalled by SpineFrontier, Inc. — Beverly, MA

FDA device recall Z-0574-2014 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). Affected quantity: 922.

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 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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0574-2014
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.

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