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U.S. Department of Health and Human Services

Class 2 Device Recall NDI Disposable Reflective Marker Spheres for Brainlab IGS system.

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  Class 2 Device Recall NDI Disposable Reflective Marker Spheres for Brainlab IGS system. see related information
Date Initiated by Firm May 20, 2015
Date Posted July 16, 2015
Recall Status1 Terminated 3 on October 13, 2017
Recall Number Z-2093-2015
Recall Event ID 71350
510(K)Number K100038  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system.

Product Usage:
Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.
Code Information 1) Catalog Number: 41773 (90 pack) Lot # C102061501
Recalling Firm/
Manufacturer		 Northern Digital Inc.
103 Randall Drive
Waterloo Canada Ontario
For Additional Information Contact Gordon Wehner
519-884-5142 Ext. 262
Manufacturer Reason
for Recall		 Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.
FDA Determined
Cause 2		 Process control
Action NDI sent an Urgent Medical Device Recall letter dated May 20, 2015 to their customers via Certified Mail. The letter identified the affected product, problem and actions to be taken. For question from Canada or the United States contact NDI at 1-877-634-6340 ext 544 and for outside North America call 1-800 634 634 00 ext 544. Customer Service can also be reached at spheres@ndigital.com.
Quantity in Commerce 32,400 spheres
Distribution Worldwide - US Nationwide Distribution and the countries of Australia and Canada.
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 = BRAINLAB, AG
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