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Type of Product	Medical Device
TGA Recall Reference	RC-2018-RN-00639-1
Product Name/Description	LFIT Anatomic CoCr V40 Femoral Head Item Numbers: 6260-9-036, 6260-9-040, 6260-9-044, 6260-9-136, 6260-9-140, 6260-9-144, 6260-9-336, 6260-9-236 Head Diameters: 36mm, 40mm and 44mm Multiple Lot Numbers ARTG Number: 211868 (Stryker Australia Pty Ltd - LFIT V40 FEMORAL HEAD - Metallic femoral head prosthesis)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	29/05/2018
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker has received a higher than expected number of complaints documenting femoral head/hip stem dissociation for certain sizes of LFIT Anatomic CoCr V40 Femoral Heads manufactured prior to 4 March, 2011.
Recall Action	Hazard Alert
Recall Action Instructions	Stryker are advising that patients implanted with an affected lot number of the LFIT Anatomic CoCr V40 Femoral Heads should continue to be reviewed as per the protocol established by his/her surgeon. There are no recommended changes to the frequency of the standard follow-up care protocol. For further information please see https://www.tga.gov.au/alert/lfit-anatomic-cocr-v40-femoral-heads . This action has been closed out on 12/02/2019
Contact Information	02 9467 1000 - Stryker