Northern Digital Inc. recalls NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable refl…

Recall date

May 20, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2093-2015

FDA classification

Class II

Brand / firm

Northern Digital Inc.

Sold / distributed

Worldwide - US Nationwide Distribution and the countries of Australia and Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.