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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00055-1
Product Name/Description	Vanguard Open Box Femoral Components VAN PS OPEN INTL FEM-RT 62.5 Item Number: 183106 Lot Number: J3849157 VAN PS OPEN INTL FEM-RT 65 Item Number: 183108 Lot Number: J3767826 VAN PS OPEN INTL FEM-LT 62.5 Item Number: 183126 Lot Number: J3844467 VAN PS OPEN INTL FEM-LT 65 Item Number: 183128 Lot Number: J3838223 VAN PS OPEN INTL FEM-LT 67.5 Item Number: 183130 Lot Number: J3778437 ARTG Number: 218510
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	18/01/2017
Responsible Entity	Zimmer Biomet Pty Ltd
Reason/Issue	As a result of inadequate line clearance between the 5th April 2016 and the 1st September 2016, the packaging of some femoral components was incorrectly labelled as either smaller or larger and/or as the incorrect side (right/left). The estimated rate of occurrence is 0.001% (<1 in 1000 products). It is highly detectable at the point of use that the device has been incorrectly labelled. At this stage, no complaints have been received for this issue.
Recall Action	Hazard Alert
Recall Action Instructions	Zimmer Biomet is advising surgeons to monitor patients through regular consultations to determine the need for any treatment. This action has been closed-out on 18/05/2017.
Contact Information	02 9483 5426 - Zimmer Biomet