Northern Digital Inc.: Medical Device Recall in 2015 - (Recall #: Z-2093-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 20, 2015

Date Posted: July 22, 2015

Recall Number: Z-2093-2015

Event ID: 71350

Reason for Recall:

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

Status: Terminated

Product Quantity: 32,400 spheres

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated