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Charger Assembly, Model # SC-5300, of the PRECISION Spinal… recallZ-0396-05 · Advanced Bionics Corporation · initiated Nov 11, 2004

Terminated All recalls posted in January 2005

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Advanced Bionics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0396-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 11, 2004
Posted by the FDA
Jan 15, 2005
Recalling firm
Advanced Bionics Corporation
Quantity
237 patients are implanted.
Product code
LGW
FDA submissions
P030017
Distribution
Nationwide

Product description

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

Code information (models, lots, serial numbers)

All Codes

Other devices under the same FDA submission

94 devices cleared under P030017 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page