NDI Disposable recall
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are…
Why was NDI Disposable recalled?
Inadequate curing of adhesive, 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) All Lots beginning with the prefix C / All expiration dates; 2) Catalog Number: 41774 (270 pack) All Lots beginning with the prefix C / All expiration dates; and 3) Catalog Number: 41813 (60 pack) All Lots beginning with the prefix C / All expiration dates
- Product
- NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are…
- Recalling firm
- Northern Digital Inc.
- Quantity
- 524, 700 spheres (41773 = 440,820 spheres; 41774 = 77,760 spheres and 41813 = 6,120 spheres)
- Distribution
- US Nationwide Distribution
- Recall date
- July 22, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)