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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 June 10, 2015
Date Posted July 16, 2015
Recall Status1 Terminated 3 on October 03, 2016
Recall Number Z-2084-2015
Recall Event ID 69804
510(K)Number K100038  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) 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) All Lots beginning with the prefix C / All expiration dates; 2) Catalog Number: 41774 (270 pack) All Lots beginning with the prefix C / All expiration dates; and 3) Catalog Number: 41813 (60 pack) All Lots beginning with the prefix C / All expiration dates
Recalling Firm/
Manufacturer		 Northern Digital Inc.
103 Randall Drive
Waterloo Canada Ontario
For Additional Information Contact Customer Service Representative
877-634-6340 Ext. 544
Manufacturer Reason
for Recall		 Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
FDA Determined
Cause 2		 Process control
Action NDI sent an Urgent Customer Notification letter dated June 10, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Acknowledgement Form attached to the notification letter and return using the enclosed pre-paid FedEx label. For questions, contact NDI at 1 (877) 634-6340 ext. 544 (if calling from North America) or +1 (800) 634 634 00 ext. 544 (if calling from outside North America) .
Quantity in Commerce 524, 700 spheres (41773 = 440,820 spheres; 41774 = 77,760 spheres and 41813 = 6,120 spheres)
Distribution US Nationwide Distribution
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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