FDA Device recall Z-2084-2015
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) 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 Surgical) system by Northern Digital, citing inadequate curing of adhesive, may cause the two halves of the spheres to separate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2084-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-10 |
| 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 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
Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
Identifiers
| code_info | 1) Catalog Number: 41773 (90 pack) All Lots beginning with the prefix C / All expiration dates; 2) Catalog Number: 4177…1) Catalog Number: 41773 (90 pack) All Lots beginning with the prefix C / All expiration dates; 2) Catalog Number: 41774 (270 pack) All Lots beginning with the prefix C / All expiration dates; and 3) Catalog Number: 41813 (60 pack) All Lots beginning with the prefix C / All expiration dates |
|---|
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-2084-2015%22
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