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Terminated

Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System

FDA Recall Z-0396-05 · Posted 2005-01-15

Recalling FirmAdvanced Bionics Corporation
Recall StatusTerminated
Product CodeLGW
Date Initiated2004-11-11
Date Terminated2005-03-08
Product Quantity237 patients are implanted.

Reason for Recall

A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.

Firm Action

Firm has notified all consignees and thier clinicians to provide them with the labeling addenda. Patient notices were sent by FedEx or by US Mail and clinicians were faxed the notice.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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