Disposable Reflective Marker Spheres The Disposable Reflective Marker… — Class II medical device recall Z-2795-2015
Terminated recall by Brainlab AG, reported 2015-09-30, distributed nationwide. Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may
| Recall number | Z-2795-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Feldkirchen, N/A, Germany |
| Recall initiated | 2015-08-18 |
| Classified | 2015-09-18 |
| Reported by FDA | 2015-09-30 |
| Terminated | 2017-01-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BH, BO, BR, CH, CL, CN, CO, CZ, DE, DK, DO, DZ, EC, EG, FI, FR, GB, HK, HU, IE, IL, IN, IQ, IR, IT, JP, KR, KW, LT, MA, MT, MX, MY, NL, PH, PL, PT, QA, SA, SG, SI, SV, TH, TR, TW, UA, VE, VN, ZA |
| Lot numbers | 1014213001, C100111501, C101021502, C101161401, C101611502, C102311401, C102481502, C103461502, C1034813001, C103881402, C104761402, C105541402, C106521402, C106721301, C107761402, C108341301, C108721402, C109051301, C109251402, C1098312001, C110411401 |
| Model numbers | 41773G |
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 for recall
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.
Machine access
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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.