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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Brainlab AG
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2795-2015
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