FDA Device recall Z-2795-2015
Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting…
- FDA Device
- Class II
- terminated
- Published 2015-09-30
On 2015-09-30 the FDA classified a Class II recall of Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting… by Brainlab Ag, citing disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may separate at the mid-point where the two halves of the sphere are seal….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2795-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-18 |
| Published | 2015-09-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Brainlab Ag |
| Distribution | US |
Product
Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. They 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. Radiology.
Reason
Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may separate at the mid-point where the two halves of the sphere are sealed together.
Identifiers
| code_info | Model numbers: 41773G Disposable Reflective Marker Sphere (90 Pcs.) 41774G Disposable Reflective Marker Sphere (270 P…Model numbers: 41773G Disposable Reflective Marker Sphere (90 Pcs.) 41774G Disposable Reflective Marker Sphere (270 Pcs.) 41772G Disposable Reflective Marker Sphere (3 Pcs) Catalogue numbers: 41773G Disposable Reflective Marker Sphere (90 Pcs.) 41774G Disposable Reflective Marker Sphere (270 Pcs.) (Note: 41772G is not available as single item for sale, but contained in the above 41773G or 41774G) Lot Numbers: 1014213001, C103461502, C107761402, C100111501, C1034813001, C108341301, C101021502, C103881402, C108721402, C101161401, C104761402, C109051301, C101611502, C105541402, C109251402, C102311401, C106521402, C1098312001, C102481502, C106721301 and C110411401. |
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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-2795-2015%22
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