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.
FDA Recall Z-2084-2015 · Posted 2015-07-16
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Recalling FirmNorthern Digital Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2015-06-10
Date Terminated2016-10-03
Product Quantity524, 700 spheres (41773 = 440,820 spheres; 41774 = 77,760 spheres and 41813 = 6,120 spheres)
Reason for Recall
Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
Firm 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) .
Root Cause
Process control
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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