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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00131-1
Product Name/Description Trinity Acetabular Shell

Multiple Part Numbers affected
Multiple Lot Codes affected

ARTG Number: 235377
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 10/02/2016
Responsible Entity Corin Australia Pty Ltd
Reason/Issue There is potential for abrasion of the sterile barrier pouches of the new packaging system which was introduced in November 2015. If this failure was to occur, it could potentially render the product non-sterile.
There have been no product complaints received about this issue to date.
Recall Action Recall
Recall Action Instructions Corin is advising users to return all affected product. Product will be replaced with stock packaged in the previous packaging system.
This action has been closed-out on 21/03/2018.
Contact Information 02 9497 7432 - Corin