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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00773-1
Product Name/Description Charcot Osteotome Chisels

Multiple Item Numbers and Products

ARTG Number: Not Notified
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 9/07/2018
Responsible Entity Zimmer Biomet Pty Ltd
Reason/Issue Zimmer Biomet, on behalf of LMT Surgical, has been made aware via complaint investigation that unexpected lumen may be present in the interface of the handle with the metal chisel. Products exhibiting this issue would not be able to be reprocessed with the validated reprocessing cycles.
Recall Action Recall
Recall Action Instructions Zimmer Biomet is advising customers to return all affected product.
This item is no longer supplied in Australia.

This action has been closed out on the 22/11/2018.
Contact Information 02 9483 5426 - Zimmer Biomet