Device product
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) 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-2084-2015
Product summary
- Event
- Event 69804
- Status
- Terminated
- Classification
- Class II
- Quantity
- 524, 700 spheres (41773 = 440,820 spheres; 41774 = 77,760 spheres and 41813 = 6,120 spheres)
- Official record key
device-enforcement:Z-2084-2015
Official wording
Reason: Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
Code information: 1) Catalog Number: 41773 (90 pack) All Lots beginning with the prefix C / All expiration dates; 2) Catalog Number: 41774 (270 pack) All Lots beginning with the prefix C / All expiration dates; and 3) Catalog Number: 41813 (60 pack) All Lots beginning with the prefix C / All expiration dates
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Inadequate curing of adhesive, may cause the two halves of the spheres to separate.