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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00275-1
Product Name/Description TOPAZ MicroDebrider Wand (used for ablation and microdebridment in the tendons of the ankles, knees and shoulders)

Product Number: ACH4040-01

All batches affected

ARTG Number: 221504
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 11/03/2016
Responsible Entity Smith & Nephew Pty Ltd
Reason/Issue TOPAZ MicroDebrider Wands has failed to meet shelf-life at the expiration date indicated on the product labels during internal functional testing. It has been found that saline may leak from the proximal end of the handle during use, and the spacer between the active and return electrodes may be displaced. This can potentially lead to the spacer being unintentionally retained in a patient, which may lead to a prolonged procedure time.
Recall Action Recall
Recall Action Instructions Smith & Nephew is advising users to discontinue use and return the affected product. Smith & Nephew will be able to provide users with alternate products. This action has been closed-out on 25/01/2017.
Contact Information 02 9857 3908 - Smith & Nephew