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Terminated

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.

FDA Recall Z-1441-2012 · Posted 2012-04-19

Recalling FirmAdvanced Bionics Corporation
Recall StatusTerminated
Product CodeLGW
Date Initiated2008-04-22
Date Terminated2012-04-19
Product Quantity6 Units

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.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution including Great Britian

Official Source

View FDA Recall →

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

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