Device product
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres 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.
Z-2093-2015
Product summary
- Event
- Event 71350
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32,400 spheres
- Official record key
device-enforcement:Z-2093-2015
Official wording
Reason: Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.
Code information: 1) Catalog Number: 41773 (90 pack) Lot # C102061501
Distribution pattern: Worldwide - US Nationwide Distribution and the countries of Australia and Canada.
Derived failure modes
-
Unknown
Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.