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U.S. Department of Health and Human Services

Class 2 Device Recall BioTex Reusable Adapter Kit

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  Class 2 Device Recall BioTex Reusable Adapter Kit see related information
Date Initiated by Firm February 22, 2016
Create Date March 24, 2016
Recall Status1 Terminated 3 on June 15, 2016
Recall Number Z-1234-2016
Recall Event ID 73337
510(K)Number K003201  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization

The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned by the physician via stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation Image Guided Workstation System.
Code Information The adapter kits are not identified with any lot/code numbers. The BioTex Adapter kits were manufactured between 2008 and 2010.
Recalling Firm/
Manufacturer
Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact
720-890-3200
Manufacturer Reason
for Recall
Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA.
FDA Determined
Cause 2
No Marketing Application
Action The firm, Medtronic, sent an "URGENT Medical Device Recall" letter dated 2/2016 to its consignees. The letter described the product, problem and actions to be taken. The identified consignees will be visited by the assigned Medtronic field representative to explain the need for the field action. The consignees are instructed to locate and remove/secure the kit from use. The Medtronic field representative will assist the consignee with identifying and removing the kit, and complete a Customer Visit record for each consignee they are assigned/visit to document the results of their visit. The consignee is instructed to sign the customer visit form presented by the representative. A copy of this record and a letter explaining the FCA will be left with the consignee. Please contact Medtronic Technical Services at 1-800-595-9709 if you have any questions regarding the subject action or the content of the letter.
Quantity in Commerce 4
Distribution US Distribution to states of: FL, NJ, AZ, and NC.
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 = HAW and Original Applicant = MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
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