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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00938-1
Product Name/Description Twinfix Quick-T Knot Pusher Suture Cutters

Product Number: 7209417

Batch Numbers: 50412843, 50477278, 50527184

ARTG Number: 112714
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 14/07/2016
Responsible Entity Smith & Nephew Pty Ltd
Reason/Issue Smith & Nephew have identified a packaging issue through internal testing. The Twinfix Quick-T Knot Pusher Suture Cutter could be subject to breaches of its sterile packaging. In the event the device is presented for use and a breach in the sterile barrier is not noticed, a non-sterile device could enter the surgical field. Smith & Nephew has received no customer complaints indicating a packaging breach or a post-operative infection.
Recall Action Recall
Recall Action Instructions Smith & Nephew is advising users to discontinue use of affected products and quarantine the device(s). The devices are to be returned to Smith & Nephew.
This action has been closed-out on 20/03/2018.
Contact Information 02 9857 3908 - Smith & Nephew