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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01194-1
Product Name/Description Ardis Inserter (intended for delivery of the Ardis interbody spacer into the prepared disc space)

Part Number: 3256-01

ARTG Number: 157926
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 26/11/2012
Responsible Entity Zimmer Pty Ltd
Reason/Issue The Ardis system implant may break when excessive lateral forces are applied to the implant during insertion.
Recall Action Recall for Product Correction
Recall Action Instructions Updated surgical technique guidance has been issued directly to surgeons to reduce the risk of off-axis loading when using the inserter.
Contact Information 1800 803 263 - Zimmer Customer Service