Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2084-2015 — 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 t

U.S. FDA — Device Enforcement · Canada · 2015-06-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2084-2015
Date of alert: 2015-06-10
Country / jurisdiction: Canada
Risk level: Class II
Risk type: recall
Brand: Northern Digital Inc.
Product category: device
Product type: Devices

Reported risk: Inadequate curing of adhesive, may cause the two halves of the spheres to separate.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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