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.
This recall has been terminated (originally issued January 10, 2007).
- Recall Initiated
- September 21, 2006
- Posted
- January 10, 2007
- Terminated
- January 25, 2012
- Recall Number
- Z-0299-2007
- Quantity
- 18
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide.
Lot / Code Info
Serial Numbers: 111744, 112122, 112141, 112224, 112233, 114114, 116547, 116553, 117860, 117907, 110490, 100600, 110625, 110809, 113745, 113780, 112055 and 118943
Root Cause
Other
Action Taken
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.