Z-2084-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2015
- Initiation Date
- June 10, 2015
- Termination Date
- October 3, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 524, 700 spheres (41773 = 440,820 spheres; 41774 = 77,760 spheres and 41813 = 6,120 spheres)
Product Description
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.
Reason for Recall
Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
Distribution Pattern
US Nationwide Distribution
Code Information
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