Recall Z-2093-2015 ยท HAW Neurological Stereotaxic Instrument
Northern Digital Inc.
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 instruments in the surgical field.
| Date | Jul 16, 2015 (initiated May 20, 2015) |
| Status | Terminated |
| Reason | Inadequate curing of adhesive, which may cause the two halves of the spheres to separate. |
| Root cause | Process control |
| Action | NDI sent an Urgent Medical Device Recall letter dated May 20, 2015 to their customers via Certified Mail. The letter identified the affected product, problem and actions to be taken. For question from Canada or the United States contact NDI at 1-877-634-6340 ext 544 and for outside North America call 1-800 634 634 00 ext 544. Customer Service can also be reached at spheres@ndigital.com. |
| Quantity | 32,400 spheres |
| Distribution | Worldwide - US Nationwide Distribution and the countries of Australia and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100038 | DISPOSABLE REFLECTIVE MARKER SPHERES Brainlab AG, Jul 14, 2010 |