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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01020-1
Product Name/Description	Optimys Opening Broach Bent (Reusable surgical instrument used for opening the medullary canal) Article Number: 51.34.0079 Lot Number: 6054883 ARTG Number: 184413
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	17/10/2013
Responsible Entity	Mathys Orthopaedics Pty Ltd
Reason/Issue	Mathys Ltd Bettlach has been notified of an incident in Switzerland where the optimys Opening Broach broke intraoperatively and the fragment was left in the bone. In the course of the investigations, it became apparent that the Opening Broach Bent may exhibit surface defects in the hewn portion which may favour breakage in case of non-compliant usage.
Recall Action	Recall
Recall Action Instructions	Replacement products made of more suitable material are being manufactured and will be provided to customers as soon as they become available. In the interim, customers are reminded on the correct usage of the device according to the surgical technique.
Contact Information	02 9417 9200 - Mathys Orthopaedics