Reported Sep 30, 2015 · Terminated
Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic…
Brainlab AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Brainlab AG · Kapellenstrasse 12 · Feldkirchen, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 Model numbers: 41773G Disposable 2 Reflective Marker Sphere (90 Pcs.) 41774G Disposable 3 Reflective Marker Sphere (270 Pcs.) 41772G Disposable 4 Reflective Marker Sphere (3 Pcs) Catalogue numbers: 41773G Disposable 5 Reflective Marker Sphere (90 Pcs.) 41774G Disposable 6 Reflective Marker Sphere (270 Pcs.) (Note: 41772G is not available as single 7 item for sale, but contained in the above 41773G or 41774G) 8 Lot Numbers: 1014213001, C103461502, C107761402, C100111501, C1034813001, C108341301, C101021502, C103881402, C108721402, C101161401, C104761402, C109051301, C101611502, C105541402, C109251402, C102311401, C106521402, C1098312001, C102481502, C106721301 and C110411401. - Amount recalled
- For 28 US consignees, 9,900 Disposable reflective marker spheres ***For 451 non-US consignees, 359,280 Disposable reflective marker spheres
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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