FDA Medical Device Recalls (openFDA)
Northern Digital Inc.: 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.
- Recall number
- Z-2084-2015
- Recalling firm
- Northern Digital Inc.
- 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.
- Status
- Terminated
- Initiated
- 2015-06-10
- Posted
- 2015-07-16
- Terminated
- 2016-10-03
- Reason
- Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
- Root cause
- 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
- 524, 700 spheres (41773 = 440,820 spheres; 41774 = 77,760 spheres and 41813 = 6,120 spheres)
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K100038"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 3002743211
- Firm city
- Waterloo Canada
- Firm state
- Ontario
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28