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Class 2 Device Recall Mini Cannulated Titanium Headed and Headless Screw Set |
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Date Initiated by Firm |
April 25, 2013 |
Date Posted |
September 22, 2014 |
Recall Status1 |
Terminated 3 on January 26, 2016 |
Recall Number |
Z-2679-2014 |
Recall Event ID |
67727 |
510(K)Number |
K120493
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Product Classification |
Screw, fixation, bone - Product Code HWC
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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
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Manufacturer Reason for Recall |
Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = HWC and Original Applicant = INSTRATEK, INC.
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