CLASS II Device recall · Reported 30 Sep 2015 · FDA Enforcement Report
Disposable Reflective Marker Spheres The Disposable recalled
Brainlab is recalling Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in, distributed nationwide in the US. The recall was initiated on 18 Aug 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2795-2015
- FDA event ID
- 71996
- Recalling firm
- Brainlab, Feldkirchen, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Aug 2015
- FDA classified
- 18 Sep 2015
- Reported
- 30 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Spinal Implants
Timeline
| 18 Aug 2015 | Recall initiated by company | |
| 18 Sep 2015 | Classified by FDA | +31 days |
| 30 Sep 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArizonaCaliforniaConnecticutIdahoIllinoisKentuckyLouisianaMassachusettsMichiganNew YorkOhioPennsylvaniaPuerto RicoTennesseeTexas
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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