Z-2084-2015Class II

NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system

Name: Z-2084-2015 NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system
Creator: Northern Digital Inc.
Published: 2015-06-10
License: https://open.fda.gov/license/

Northern Digital Inc. / initiated 2015-06-10 / Terminated / root cause: manufacturing process

FDA source

Northern Digital Inc. began a recall of NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to... on 2015-06-10. FDA classified it as Class II and gives the reason as "Inadequate curing of adhesive, may cause the two halves of the spheres to separate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2084-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-10
Posted: 2015-07-16
Terminated: 2016-10-03
Recalling firm: Northern Digital Inc.
Product: 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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
Root cause tag: manufacturing process
FDA 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 in commerce: 524, 700 spheres (41773 = 440,820 spheres; 41774 = 77,760 spheres and 41813 = 6,120 spheres)
Distribution: US Nationwide Distribution
Product codes and lots: 1) Catalog Number: 41773 (90 pack) All Lots beginning with the prefix C / All expiration dates; 2) Catalog Number: 41774 (270 pack) All Lots beginning with the prefix C / All expiration dates; and 3) Catalog Number: 41813 (60 pack) All Lots beginning with the prefix C / All expiration dates

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2084-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2084-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-15

Product code HAW

K100038Class IIDisposable Reflective Marker SpheresBrainlab AG / cleared 2010-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)