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Precision Implantable Pulse Generator (IPG), Model Number… recallZ-0055-2008 · Advanced Bionics Corp · initiated Aug 3, 2007

Terminated All recalls posted in October 2007

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 Corp 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

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

FDA root cause category: Error in labeling

What the company is doing

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.

Recall details

Recall number
Z-0055-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 3, 2007
Posted by the FDA
Oct 12, 2007
Recalling firm
Advanced Bionics Corp
Quantity
1 unit affected
Product code
LGW
FDA submissions
P030017
Distribution
MD

Product description

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

Code information (models, lots, serial numbers)

Model Number SC-1110, Serial Number 161767

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