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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.

FDA Recall Z-0299-2007 · Posted 2007-01-10

Recalling FirmAdvanced Bionics Corporation
Recall StatusTerminated
Product CodeLGW
Date Initiated2006-09-21
Date Terminated2012-01-25
Product Quantity18

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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