Home / Recalls / Northern Digital Inc. / Z-2093-2015

Z-2093-2015 Class II Terminated

Recalled by Northern Digital Inc. — Waterloo, Ontario

Recall Details

Product Type: Devices
Report Date: July 22, 2015
Initiation Date: May 20, 2015
Termination Date: October 13, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 32,400 spheres

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

1) Catalog Number: 41773 (90 pack) Lot # C102061501