NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable refl
FDA device recall Z-2084-2015 · posted 2015-07-16 · Terminated
Recall details
- Recalling firm
- Northern Digital Inc.
- Reason for recall
- Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
- Action taken
- 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) .
- Root cause
- Process control
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 524, 700 spheres (41773 = 440,820 spheres; 41774 = 77,760 spheres and 41813 = 6,120 spheres)
- Distribution
- US Nationwide Distribution
- Date initiated
- 2015-06-10
- Date posted
- 2015-07-16
- Date terminated
- 2016-10-03
- Location
- Waterloo Canada, Ontario
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE REFLECTIVE MARKER SPHERES (K100038) | Brainlab AG | 2010-07-14 |