NDI Disposable Reflective Marker Spheres Recalled for Adhesive Defect
Northern Digital Inc. is recalling NDI Disposable Reflective Marker Spheres because inadequate adhesive curing may cause the spheres to separate.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device used in surgical settings where component separation could pose a risk of harm, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Northern Digital Inc. is recalling NDI Disposable Reflective Marker Spheres used with the Brainlab IGS (Image Guided Surgical) system. The recall involves 524,700 spheres across three catalog numbers: 41773, 41774, and 41813. The affected units are all lots beginning with the prefix C and all expiration dates.
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 product was distributed nationwide in the United States. The FDA has classified this as a Class II recall. Users should stop using the affected spheres and contact Northern Digital Inc. for instructions on return or replacement.
The recalled product
- Product
- NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) 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…
- Manufacturer
- Northern Digital Inc.
Distribution
Distributed nationwide across the United States.
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