Z-0894-2013 Class II Terminated
FDA device recall Z-0894-2013 was initiated by Advanced Neuromodulation Systems Inc. on March 28, 2012 and is designated Class II. Reason for recall: Unintended Fluid ingress into the device header has been shown. The recall status is terminated (terminated August 15, 2013). Affected quantity: 388 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2013
- Initiation Date
- March 28, 2012
- Termination Date
- August 15, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 388 units
Product Description
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
Reason for Recall
Unintended Fluid ingress into the device header has been shown.
Distribution Pattern
Worldwide Distribution - 53 consignees out of the US.
Code Information
Model number 6788. All lots manufactured prior to 03/16/2012 are being recalled.