Brainlab AG: 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.

Recall number

Z-2795-2015

Recalling firm

Brainlab AG

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.

Status

Terminated

Initiated

2015-08-18

Posted

not on file

Terminated

2017-01-05

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.

Root cause

Process control

Action

The firm, Brainlab AG, sent out a" FIELD SAFETY NOTICE/ PRODUCT NOTIFICATION" dated 7/23/2015 to its customers. The firm sent this letter to mitigate the potential effects of the affected Disposable Reflective Marker Spheres (DRMS) when used with Brainlab Image Guided Surgery (IGS) systems. The firm advised the medical users that they should take the following steps prior to each procedure using Brainlab DRMS spheres for Brainlab IGS systems: -Prior to opening the package containing the spheres, visually inspect the spheres in the blister pack for any signs of separation between the two halves of the sphere. If there is any indication that the spheres may have separated, use a different blister pack for the procedure and repeat this step with the new pack. Discard any and all affected spheres and inform your Brainlab support representative about the occurrence of the issue. If there is no visual sign of sphere separation, proceed to the next step. -Prior to the start of the procedure, screw each DRMS sphere onto the tool and tighten. Upon tightening, inspect again to determine whether any separation between the two halves is evident. If separation is evident, remove and discard the affected sphere. Replace your surgical gloves, then replace the separated sphere with a new sphere, inspecting it as above. If no separation is evident, proceed with the clinical procedure. -Be sure to discard and replace your surgical gloves any time that a sphere with evident separation is found upon affixing the sphere to the tool, and every time after a separated sphere was touched. -Caution: Do not affix the sphere to the tool over the surgical area to minimize the risk of a sphere, or any portion thereof, falling onto the patient or into the surgical wound. Also avoid affixing the sphere over other sterile areas (such as surgical trays) to minimize potential contamination in case of sphere separation. -Reminder: In general, do not use defective or deformed marker

Quantity

For 28 US consignees, 9,900 Disposable reflective marker spheres ***For 451 non-US consignees, 359,280 Disposable reflective marker spheres

Distribution

Worldwide Distribution: US (nationwide) including states of: TX, CA, TN, NY, LA, IL, MA, PA, OH, AZ, ID, CT, MI, and KY; and countries of: Algeria, Argentina, Australia, Bahrain, Belarus, Bolivia, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Malaysia, Malta, Mexico, Moldova, Morocco, Myanmar, Netherlands, Philippines, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, , Venezuela, and Vietnam.

Lot, serial or model codes

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.

510(k) numbers

["K100038"]

PMA numbers

not on file

Product code

HAW

Firm FEI

3002619595

Firm city

Feldkirchen

Firm state

not on file

Firm country

Germany

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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