🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: May 20, 2015 Northern Digital Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    1) Catalog Number: 41773 (90 pack) Lot # C102061501
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Northern Digital Inc.
Reason for Recall:
Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2093-2015

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