Z-1441-2012

OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord...

Name: Z-1441-2012 OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord...
Creator: Advanced Bionics Corporation
Published: 2008-04-22
License: https://open.fda.gov/license/

Advanced Bionics LLC / initiated 2008-04-22 / Terminated / root cause: labeling and UDI

FDA source

Advanced Bionics Corporation began a recall of OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator System is indicated as an aid in the management... on 2008-04-22. The reason FDA records is "The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1441-2012
Status: Terminated
Initiated: 2008-04-22
Posted: 2012-04-19
Terminated: 2012-04-19
Recalling firm: Advanced Bionics LLC
Product: 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.
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 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.
Quantity in commerce: 6 Units
Distribution: Worldwide Distribution including Great Britian
Product codes and lots: Model Number: SC-9305, Lot Number 170338

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)