Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30
FDA device recall Z-0299-2007 · posted 2007-01-10 · Terminated
Recall details
- Recalling firm
- Advanced Bionics Corporation
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LGW
- Quantity affected
- 18
- Distribution
- Worldwide.
- Date initiated
- 2006-09-21
- Date posted
- 2007-01-10
- Date terminated
- 2012-01-25
- Location
- Sylmar, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.