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, which may cause the two halves of the spheres to separate. |
| 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. |
| Quantity | 32,400 spheres |
| Distribution | Worldwide - US Nationwide Distribution and the countries of Australia and Canada. |
| Initiated | 2015-05-20 |
| Classified | 2015-07-16 |
| Terminated | 2017-10-13 |
| Recall number | Z-2093-2015 |
| 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-2093-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71350/
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