Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342
Lot Codes / Batch Numbers
Model Number: SC-9305, Lot Number 170338
Products Sold
Model Number: SC-9305, Lot Number 170338
Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342 is recalling OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord due to The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026