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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:

Lot Number: 223007

Lot Numbers: 220788, 230952 & 233742

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