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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01019-1
Product Name/Description Triathlon MIS Modular Distal Capture
(optional tool which can be attached to the distal resection guide to complete the cut)

Part Number: 6541-5-723

Lot Numbers: AF1C11, AF1C11M, AF1E01D, AF1E01MX3, AF1T43, AF8V03

ARTG Number: 140892
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 20/10/2015
Responsible Entity Stryker Australia Pty Ltd
Reason/Issue Stryker has received customer complaints regarding the Triathlon MIS Modular Distal Capture device disassociating during use.
This may result in one or more of the following potential patient harms:

· Complications associated with extended surgery time
· Inflammation / inflammatory response.
· Revision surgery to retrieve loose spring.
Recall Action Recall
Recall Action Instructions Stryker is advising users to inspect stock and quarantine any affected units. Affected units will be replaced with unaffected stock. This action has beem closed-out on 05/12/2016.
Contact Information 1800 803 601 - Stryker Australia