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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00587-1
Product Name/Description Aequalis IM Nail Targeting Jig
(Prosthetic joint implantation kit)

Lots: All lots - (DB0114069, DB0114349, CA46096, CA216052, DB0111264001, DB0112016, DB0113102)

Catalogue Number: 9020060

ARTG number: 177214
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 7/07/2015
Responsible Entity Tornier Pty Ltd
Reason/Issue The targeting jig mast is separating from the jig boom. Any separation will impact alignment and can affect the ability to fixate the screws.
There has been no impact to a patient to-date; however, a design change to the product is necessary.
Recall Action Recall
Recall Action Instructions Tornier is developing a design change for the jig. Once the design change has been completed Tornier will arrange for the collection and replacement of the faulty devices. In the interim, Tornier has provided inspection instructions to ensure that faulty devices are not used in surgery.

This action has been closed out on 24/10/2018
Contact Information 02 9451 2244 - Wright