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.
FDA Recall Z-2093-2015 · Posted 2015-07-16
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Recalling FirmNorthern Digital Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2015-05-20
Date Terminated2017-10-13
Product Quantity32,400 spheres
Reason for Recall
Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.
Firm 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 [email protected].
Root Cause
Process control
Distribution Pattern
Worldwide - US Nationwide Distribution and the countries of Australia and Canada.
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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