Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00493-3
Product Name/Description ABGII Modular Stems and ABGII Modular Necks (An exchangeable modular neck, designed to allow intra-operative flexibility for bio mechanical adjustment of offset and anteversion without affecting leg length)

Multiple Catalogue Numbers

All lot numbers

ARTG Number: 145647
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/07/2012
Responsible Entity Stryker Australia Pty Ltd
Reason/Issue This action is occurring worldwide because of a high incidence of wear, known as fretting and corrosion, at the join between the femoral stem and the neck component. Fretting and corrosion can result in metal debris in and around the hip joint. If this occurs, patients may experience inflammation, adverse local tissue reactions (ALTRs), hypersensitivity/allergic reactions and osteolysis (bone loss)
Recall Action Hazard Alert
Recall Action Instructions The ABGII Modular Femoral Stem and Modular Neck has been cancelled from the Australian Register of Therapeutic Goods (ARTG). Stryker Australia Pty Ltd has contacted orthopaedic surgeons who has ever implanted the ABGII modular hip replacement system. Those surgeons have been asked to contact their patients to discuss what clinical action is most appropriate. For more details, please see and .
Contact Information 1800 803 601 - Eric Carlson