| 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 |
|
| 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 https://www.tga.gov.au/alert/abgii-modular-femoral-stem-and-modular-neck-hip-replacement-system and https://www.tga.gov.au/alert/abgii-modular-femoral-stem-and-modular-neck-hip-replacement-system-update . |
| Contact Information |
1800 803 601 - Eric Carlson |