FDA Medical Device Recalls (openFDA)
Northern Digital Inc.: 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.
- Recall number
- Z-2093-2015
- Recalling firm
- Northern Digital Inc.
- 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.
- Status
- Terminated
- Initiated
- 2015-05-20
- Posted
- 2015-07-16
- Terminated
- 2017-10-13
- Reason
- Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.
- Root cause
- 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
- 32,400 spheres
- Distribution
- Worldwide - US Nationwide Distribution and the countries of Australia and Canada.
- Lot, serial or model codes
- 1) Catalog Number: 41773 (90 pack) Lot # C102061501
- 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