Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:25278
Brand Name:CUSA Clarity : console & footswitch
Model:CUSA Clarity Console (C7000) - all serial numbers
Affected:
Software version:
Recalling Organisation:Integra Neurosciences Pty Ltd (NZ)
12 Florence Avenue
Orewa
Auckland 0931
Contact Information:0800 400 660
Manufacturer:Integra Lifesciences (Ireland) Ltd
Issue:The manufacturer has discovered that the Operator's Manual needed revision to reflect the most accurate sterilization parameters. The dry time parameters have been changed from 30 minutes to 40 minutes for the CUSA Clarity 36kHz handpiece and components, consistent with the CUSA Clarity 23kHz handpiece and components.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:23/10/2019
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