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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01191-1
Product Name/Description	LFIT Anatomic CoCr V40 Femoral Heads (Modular components used in total hip replacement procedures) Item: 6260-9-236 Head diameter 36mm; Offset +5 Item: 6260-9-240 Head diameter 40mm; Offset +4 Item: 6260-9-244 Head diameter 44mm; Offset +4 Item: 6260-9-340 Head diameter 40mm; Offset +8 Item: 6260-9-440 Head diameter 40mm; Offset +12 Item: 6260-9-344 Head diameter 44mm; Offset +8 Item: 6260-9-444 Head diameter 44mm; Offset +12 Multiple lot numbers affected ARTG #: 211868
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	19/09/2016
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker has identified a non-conformance due to a trend analysis showing an incidence of taper lock failures higher than the predicted rate (>0.05%) for four LFIT Anatomic CoCr V40 Femoral Heads manufactured prior to 2011. The increased incidence of taper lock failures relates to possible taper lock interface inconsistency. Potential hazards include disassociation of femoral head from hip stem, fractured hip stem trunnion, increased metallic debris, insufficient range of motion, insufficient soft tissue tension, noise, loss of implant, bone fixation strength, increased wear debris (polymeric), implant construct with a shortened neck length.
Recall Action	Hazard Alert
Recall Action Instructions	Stryker is advising that patients implanted with an affected lot number of the LFIT Anatomic CoCr V40TM Femoral Heads should continue to be followed per the normal protocol established by his/her surgeon. This action has been closed-out on 20/03/2018.
Contact Information	02 9467 1000 - Stryker