NDI Disposable Reflective Marker Spheres for Brainlab IGS — Class II medical device recall Z-2084-2015
Terminated recall by Northern Digital Inc., reported 2015-07-22, distributed nationwide. Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
| Recall number | Z-2084-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Northern Digital Inc., Waterloo, Ontario, Canada |
| Recall initiated | 2015-06-10 |
| Classified | 2015-07-15 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2016-10-03 |
| Distributed | Nationwide (US) |
| Model numbers | 41773, 41774, 41813 |
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.
Reason for recall
Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2084-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.