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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00563-1
Product Name/Description	INFUSE/LT Cage Bone Graft Kit (Used for spinal fusion procedures) Catalogue Numbers 7510200AUS / SMALL, 7510400AUS / MEDIUM, 7510800AUS / LARGE Lot Numbers: M111052AAM, M111052AAT, M111054AAR, M111059AAE, M111063AAE, M111063AAF, M111063AAK, M111063AAO, M111064AAH, M111064AAN, M111103AAC ARTG 121164
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	13/06/2013
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Multiple lots of INFUSE/LT Cage Bone Graft Kit is affected due to an issue with Absorbable Collagen Sponge (ACS) which is a component of the INFUSE/LT Cage Bone Graft Kit. The component supplier, Integra LifeSciences Corporation has advised Medtronic that a manufacturing process deviation may have resulted in some lots of Absorbable Collagen Sponge being released and supplied to Medtronic with higher levels of endotoxins than permitted by the specifications for the products. Higher endotoxin levels may result in a fever in the immediate postoperative period. Medtronic are not aware of any reports of patient injuries or other adverse events in connection with this issue.
Recall Action	Hazard Alert
Recall Action Instructions	Medtronic is recalling the affected product and is asking clinicians through the 'hazard alert' to monitor their patients in the postoperative period in accordance with standard hospital or clinician protocol. For more details, please see http://www.tga.gov.au/safety/alerts-device-infuse-130627.htm .
Contact Information	02 9857 9139 - Product Manager