FDAClass IIJuly 22, 2015

NDI Disposable recall

NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are…

Why was NDI Disposable recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are…
Recalling firm
Northern Digital Inc.
Quantity
32,400 spheres
Distribution
Worldwide - US Nationwide Distribution and the countries of Australia and Canada.
Recall date
July 22, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls