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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00699-1
Product Name/Description	Triathlon Tibial Alignment Ankle Camp Extramedullary (Referencing Instrument supplied with Triathlon Total Knee Arthroplasty procedure kit) Catalogue Number: 65412609 All lot numbers ARTG No: 140892
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	10/07/2013
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker Orthopaedics has received complaints associated with cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp. As a result, there exists the potential for complications associated with extended surgery time greater than thirty minutes to retrieve a replacement ankle clamp.
Recall Action	Recall for Product Correction
Recall Action Instructions	Stryker is providing surgeons with work around instructions to implement if they are presented with a compromised Tibial Alignment Clamp during surgery.
Contact Information	02 9467 1052 - Stryker Orthopaedics