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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