Recall Z-2084-2015 ยท HAW Neurological Stereotaxic Instrument
Northern Digital Inc.
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.
| Date | Jul 16, 2015 (initiated Jun 10, 2015) |
| Status | Terminated |
| Reason | Inadequate curing of adhesive, may cause the two halves of the spheres to separate. |
| Root cause | Process control |
| Action | NDI sent an Urgent Customer Notification letter dated June 10, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Acknowledgement Form attached to the notification letter and return using the enclosed pre-paid FedEx label. For questions, contact NDI at 1 (877) 634-6340 ext. 544 (if calling from North America) or +1 (800) 634 634 00 ext. 544 (if calling from outside North America) . |
| Quantity | 524, 700 spheres (41773 = 440,820 spheres; 41774 = 77,760 spheres and 41813 = 6,120 spheres) |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100038 | DISPOSABLE REFLECTIVE MARKER SPHERES Brainlab AG, Jul 14, 2010 |