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Northern Digital Inc. recalls NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposabl
Recalled July 22, 2015 · FDA recall Z-2084-2015 · Northern Digital
Hazard
Inadequate curing of adhesive, may cause the two halves of the spheres to separate. · FDA Class II
Units
524, 700 spheres (41773 = 440,820 spheres; 41774 = 77,760 spheres and 41813 = 6,120 spheres)
Sold at
US Nationwide Distribution
Description
Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
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.
Manufacturer(s)
Northern Digital Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →