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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00882-1
Product Name/Description 6.5 Cancellous Bone Screw 35mm (Used in total hip joint arthroplasty when the surgeon elects to use a cluster/multi-hole shell in the acetabulum prosthetic component)

Catalogue Number: 2030-6535-1

Lot Numbers: MLH17R, MLJDJT and MLH3K8
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 31/08/2012
Responsible Entity Stryker Australia Pty Ltd
Reason/Issue Stryker Orthopaedics has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are potentially associated with a product label mix. The packaging label associated with a 35mm screw may contain a 25mm screw.
Recall Action Recall
Recall Action Instructions Recall and replacement of affected lots
Contact Information 1800 803 601 - Lachlan Mckenzie