Northern Digital recalls disposable reflective marker spheres for surgical tracking
Northern Digital Inc. is recalling 32,400 disposable reflective marker spheres used in Brainlab IGS systems due to inadequate adhesive curing that may cause the spheres to separate.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (surgical tracking device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Northern Digital Inc. is recalling 32,400 units of NDI Disposable Reflective Marker Spheres intended for use with the Brainlab IGS (Image Guided Surgery) system. The recall is due to inadequate curing of the adhesive, which may cause the two halves of the spheres to separate. These spheres are attached to reference arrays and instruments to enable infrared tracking systems to detect the position of the patient and instruments in the surgical field.
The affected product is identified by Catalog Number 41773 (90 pack) and Lot # C102061501. The product was distributed worldwide, including the United States, Australia, and Canada. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take.
The recalled product
- Product
- 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
- Manufacturer
- Northern Digital Inc.
- Affected units
- 32,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 1) Catalog Number: 41773 (90 pack) Lot # C102061501
Distribution
Distributed nationwide across the United States.
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