Class 2 Device Recall Mini Cannulated Titanium Headed and Headless Screw Set

• Date Initiated by Firm: April 25, 2013
• Date Posted: September 22, 2014
• Recall Status: Terminated on January 26, 2016
• Recall Number: Z-2679-2014
• Recall Event ID: 67727
• 510(K)Number: K120493
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: 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
• Code Information: Mini System part no. IS1100 - lot 0001-0047; Instrument part nos. IS1103, IS1104, and IS1105 - lots 918101, 918102, and 918103
• Recalling Firm/ Manufacturer: Instratek, Incorporated; 15200 Middlebrook Dr; Ste G; Houston TX 77058-1216
• Manufacturer Reason for Recall: Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm plans to notify their customers of the recall via email, telephone and visit. The firm then plans to scrap and discard any affected product.
• Quantity in Commerce: 96
• Distribution: Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HWC and Original Applicant = INSTRATEK, INC.