Z-2679-2014 Class II Terminated

Recalled by Instratek, Incorporated — Houston, TX

Recall Details

Product Type
Devices
Report Date
October 1, 2014
Initiation Date
April 25, 2013
Termination Date
January 26, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
96

Product Description

Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System

Reason for Recall

Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.

Distribution Pattern

Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado

Code Information

Mini System part no. IS1100 - lot 0001-0047; Instrument part nos. IS1103, IS1104, and IS1105 - lots 918101, 918102, and 918103