Z-0575-2014 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
N/A

Product Description

Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. 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 0 16-01: Lots 0000, 000 1