FDA-Device2015-07-22Class II
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.
Northern Digital Inc.
Hazard
Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
Sold states
US Nationwide Distribution
Affected count
524, 700 spheres (41773 = 440,820 spheres; 41774 = 77,760 spheres and 41813 = 6,120 spheres)
Manufactured in
103 Randall Drive, N/A, Waterloo, Ontario, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2084-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief