FDAMay 20, 2015device

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 s...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.

What to do

FDA enforcement status: Terminated

Brands named

northern digitalnorthern

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →