FDA Recall
Terminated
Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70.
Recall: Z-0299-2007
·
Initiated September 21, 2006
Recall
- Recall Number
- Z-0299-2007
- Event Number
- 36624
- Firm
- Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342
- FEI Number
- 1000220815
- Product Code
- LGW
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 21, 2006
- Posted
- January 10, 2007
- Terminated
- January 25, 2012
Description
Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70.
Reason
A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient.
Action
In United States, the clinician recall notification letters were distributed by Fed-Ex or U.S. Postal Service certified mail on 09/21/2006. For the other regions, the in-country representatives started providing notification to the clinicians on 09/21/2006. The recall notification letters will instruct physicians to immediately return the unimplanted units.
Distribution
Worldwide.
Quantity
18