Reported Jul 22, 2015 · Terminated
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable…
Northern Digital Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Northern Digital Inc. · 103 Randall Drive · Waterloo, Ontario · N/A
Is this the product you have?
- NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system
- Product UsageDisposable 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
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published 41773(90 pack) All Lots beginning with the prefix C / All expiration dates 41774(270 pack) All Lots beginning with the prefix C / All expiration dates; and 41813(60 pack) All Lots beginning with the prefix C / All expiration dates - Amount recalled
- 524, 700 spheres (41773 = 440,820 spheres; 41774 = 77,760 spheres and 41813 = 6,120 spheres)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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