FDA Device recall Z-2093-2015
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system
- FDA Device
- Class II
- terminated
- Published 2015-07-22
On 2015-07-22 the FDA classified a Class II recall of NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system by Northern Digital, citing inadequate curing of adhesive, which may cause the two halves of the spheres to separate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2093-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-20 |
| Published | 2015-07-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Northern Digital |
| Distribution | US |
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.
Reason
Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.
Identifiers
| code_info | 1) Catalog Number: 41773 (90 pack) Lot # C102061501 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2093-2015%22
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