NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable refle
FDA device recall Z-2093-2015 · posted 2015-07-16 · Terminated
Recall details
- Recalling firm
- Northern Digital Inc.
- Reason for recall
- Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 32,400 spheres
- Distribution
- Worldwide - US Nationwide Distribution and the countries of Australia and Canada.
- Date initiated
- 2015-05-20
- Date posted
- 2015-07-16
- Date terminated
- 2017-10-13
- Location
- Waterloo Canada, Ontario
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE REFLECTIVE MARKER SPHERES (K100038) | Brainlab AG | 2010-07-14 |