Recall Z-2084-2015— Northern Digital Inc.
Class II · Terminated
Class II FDA medical device recall by Northern Digital Inc., initiated 2015-06-10, terminated 2016-10-03. It names one FDA 510(k) clearance: K100038. 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 and instruments in the surgical field.. Reason: Inadequate curing of adhesive, may cause the two halves of the spheres to separate..
- Recalling firm
- Northern Digital Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-10
- Terminated
- 2016-10-03
- Firm location
- Waterloo, Ontario, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 and instruments in the surgical field.
Reason for recall
Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
Data sourced from openFDA. This site is unofficial and independent of the FDA.