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 |
|
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 |