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

FDA device recall Z-1441-2012 · posted 2012-04-19 · Terminated

Recall details

Recalling firm

Advanced Bionics Corporation

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.

Action taken

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

Status

Terminated

Product code

LGW

Quantity affected

6 Units

Distribution

Worldwide Distribution including Great Britian

Date initiated

2008-04-22

Date posted

2012-04-19

Date terminated

2012-04-19

Location

Sylmar, CA