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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01062-1
Product Name/Description	"PROFEMUR R" PROX BODY PLASMA SPRAYSTD3 (femoral component of a hip joint prosthesis) Product code: PPW38363 Lot Number: X02382954 ARTG Number: 154282
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/11/2012
Responsible Entity	Wright Medical Australia Pty Ltd
Reason/Issue	The recall is being initiated because there is a label discrepancy that affects the shelf life listed on products manufactured at the Toulon, France facility. The product functions as intended, however there is not adequate justification on file to support the packaging shelf life listed on the label. There have been no reported issues related to the packaging integrity or sterility of this product. This recall is being initiated because there is a potential risk to health (such as contamination/infection) that may arise if a packaging integrity failure were to occur.
Recall Action	Hazard Alert
Recall Action Instructions	Wright Medical advises devices implanted are considered safe and are not required to be revisited.
Contact Information	1300 665 884 - Wright Medical Australia