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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71350

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 20, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Northern Digital Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2093-2015
Recall number
Z-2093-2015
Initiated
May 20, 2015
Classification
Class II
Status
Terminated
Recalling firm
Northern Digital Inc.
Quantity
32,400 spheres

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.

Code information

1) Catalog Number: 41773 (90 pack) Lot # C102061501

Distribution pattern

Worldwide - US Nationwide Distribution and the countries of Australia and Canada.