Class II — Northern Digital Inc.
| Recalling firm | NORTHERN DIGITAL, INC. |
|---|---|
| Registered facility | NORTHERN DIGITAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Inadequate curing of adhesive, may cause the two halves of the spheres to separate. |
| 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. |
| Quantity | 524, 700 spheres (41773 = 440,820 spheres; 41774 = 77,760 spheres and 41813 = 6,120 spheres) |
| Distribution | US Nationwide Distribution |
| Initiated | 2015-06-10 |
| Classified | 2015-07-15 |
| Terminated | 2016-10-03 |
| Recall number | Z-2084-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Northern Digital Inc. (Z-2084-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69804/
Alerts for NORTHERN DIGITAL, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.