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FDAFDA · Food and drugs·Recall number Z-2679-2014

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

Published October 1, 2014 · Recall initiated: April 25, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Instratek, Incorporated
Distributor
Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado
Lot
Mini System part no. IS1100 - lot 0001-0047; Instrument part nos. IS1103, IS1104, and IS1105 - lots 918101, 918102, and 918103
Risk classification
Class II
Area (FDA)
device
Country
United States

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