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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 .

This action has been closed out on 12/02/2019
Contact Information 02 9467 1000 - Stryker