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OMG (Observational Mechanical Gateway) Connector - A Model… recallZ-1441-2012 · Advanced Bionics Corporation · initiated Apr 22, 2008

Terminated All recalls posted in April 2012

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

The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual.

FDA root cause category: Labeling mix-ups

What the company is doing

Algotec Limited initiated a Field Safety Notice Urgent Medical Device Correction letter dated April 22, 2008, with Boston Scientific forwarding a recall letter to one customer who received the recalled product. The letter instructed the consignee to replace the previously packaged manual with the OMG Connector-A manual that was supplied with the notification. The replacement of the manuals is to be confirmed via the Verification form. Customers were instructed to complete and fax the Verification Form to their local Boston Scientific Customer Service to Fax 00 44 1442 411732 by 06 May 2008. For questions regarding this recall call 661-949-4481.

Recall details

Recall number
Z-1441-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 22, 2008
Posted by the FDA
Apr 19, 2012
Recalling firm
Advanced Bionics Corporation
Quantity
6 Units
Product code
LGW
FDA submissions
P030017
Distribution
Worldwide Distribution including Great Britian

Product description

OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with following: failed back surgery syndrome, intractable low back pain and leg pain. The Precision System includes an implantable l6-output, multi-channel stimulator (lPO - Implantable Pulse Generator) with a rechargeable battery power source. The lPG, commonly implanted in the abdomen or buttock area, can be configured to accept one or two leads. The leads are implanted in the epidural space, adjacent to the spinal column. The stimulation delivered at the distal end of the lead is intended to mask the pain signals.

Code information (models, lots, serial numbers)

Model Number: SC-9305, Lot Number 170338

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

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