Agency classClass IIOur severity:High FDA (Devices)·Z-2795-2015·Announced 2015-09-30

Brainlab Disposable Reflective Marker Spheres Recalled for Separation Risk

Brainlab AG is recalling Disposable Reflective Marker Spheres because they may separate at the mid-point seal, posing a risk to patients during image-guided surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used in neurosurgery where a component failure (sphere separation) could lead to injury, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Brainlab AG is recalling Disposable Reflective Marker Spheres (DRMS) used with Brainlab Image Guided Surgery (IGS) systems. The recall is due to a defect where the spheres may separate at the mid-point where the two halves are sealed together. These spheres are used in conjunction with stereotaxic instruments to enable infrared tracking systems to detect the position of patients and instruments in the surgical field.

The affected products include model numbers 41773G, 41774G, and 41772G. The recall covers 9,900 units distributed to 28 US consignees and 359,280 units distributed to 451 non-US consignees. Distribution was worldwide, including nationwide distribution in the US and various international locations.

Healthcare facilities and users should stop using the affected Disposable Reflective Marker Spheres immediately. Brainlab AG is the recalling firm responsible for managing the recall and providing instructions to affected consignees.

The recalled product

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…
Manufacturer: Brainlab AG
Category: Medical Device — Surgical Instrument
Hazard: component-separation
surgical-injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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.

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Same manufacturer · Brainlab AG

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Same hazard · component separation