Instratek, Incorporated: Medical Device Recall in 2014 - (Recall #: Z-2679-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: April 25, 2013

Date Posted: October 1, 2014

Recall Number: Z-2679-2014

Event ID: 67727

Reason for Recall:

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

Status: Terminated

Product Quantity: 96

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated