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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00232-1
Product Name/Description	Universal Clamp System and UniWallis System (used during spinal cord surgery) All lot numbers affected ARTG Number:157602
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/03/2016
Responsible Entity	Zimmer Pty Ltd
Reason/Issue	Zimmer is initiating a Recall for Product Correction to provide updated cleaning, disinfection and sterilisation instruction for use of Universal Clamp System (IFU, reference: SN2027-N-90001 and UniWallis System (IFU, references: 038WNAN0000T). Since the market launch of each products (Universal Clamp system and UniWallis system), the instruments were distributed with Instruction for use related to the method for cleaning, disinfection and for steam sterilisation at health care facilities. However, the method was not adequately validated. Instruments cleaned, disinfected, and sterilised under the former IFU for the Universal Clamp and/or UniWallis systems may not be sterile which can result in infection.
Recall Action	Recall for Product Correction
Recall Action Instructions	Zimmer is providing users with revised Instructions for Use and advising users to discard the previous IFU.
Contact Information	02 9483 5426 - Zimmer Biomet