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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00449-1
Product Name/Description	Tension Band Pins (Internal fixation pins) Part Numbers: TB-1550K-S Lot Number: 223007 TB-1570K-S Lot Numbers: 220788, 230952 & 233742 TB-1590K-S Lot Numbers: 218700, 221465 & 223009 ARTG Number: 99821
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	9/05/2014
Responsible Entity	Medical & Optical Instruments Australia Pty Ltd
Reason/Issue	Specific lots of tension band pins manufactured between July 2009 and March 2011 are being recalled because they were manufactured with ASTM F138 stainless steel but should have been manufactured with ASTM A276 stainless steel. Both standards are grade 316L stainless steel and contain the exact same chemical elements but in different concentrations. Although the biocompatibility was only tested on ASTM F138 there is no evidence to indicate that ASTM A276 is not biocompatible.
Recall Action	Recall
Recall Action Instructions	Medical + Optical is contacting their customers to arrange for the return of affected devices.
Contact Information	1800 225 065 - Medical + Optical Instruments Australia Pty Ltd