Z-2093-2015 Class II Terminated
FDA device recall Z-2093-2015 was initiated by Northern Digital Inc. on May 20, 2015 and is designated Class II. Reason for recall: Inadequate curing of adhesive, which may cause the two halves of the spheres to separate. The recall status is terminated (terminated October 13, 2017). Affected quantity: 32,400 spheres.
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2015
- Initiation Date
- May 20, 2015
- Termination Date
- October 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,400 spheres
Product 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.
Reason for Recall
Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.
Distribution Pattern
Worldwide - US Nationwide Distribution and the countries of Australia and Canada.
Code Information
1) Catalog Number: 41773 (90 pack) Lot # C102061501