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Terminated

Precision Implantable Pulse Generator (IPG), Model Number SC-110

FDA Recall Z-0055-2008 · Posted 2007-10-12

Recalling FirmAdvanced Bionics Corp
Recall StatusTerminated
Product CodeLGW
Date Initiated2007-08-03
Date Terminated2012-01-25
Product Quantity1 unit affected

Reason for Recall

Mislabeled: Product labeled with the incorrect shelf-life information.

Firm Action

There was one unit affected by this field action. An Advanced Bionics representative contacted and visited the facility on August 3, 2007. At this time, the affected device has been retrieved by the Company.

Root Cause

Error in labeling

Distribution Pattern

MD

Official Source

View FDA Recall →

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

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