| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00154-1 |
| Product Name/Description |
GENESIS II KNEE SYSTEM – Non Porous Tibial Base Plate
Model Number: 71420182
Batch Number: 14CT39993
ARTG Number: 207027 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Batch Number 14CT39993 of the GENESIS II Knee System non-porous tibial base plate (Model # 71420182) were manufactured with a surface finish that does not meet Smith & Nephew’s product specification. This could result in poor cement adherence and the loosening of base plate. The device may fail, and revision surgery may be required. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Smith & Nephew is recommending that surgeons follow standard post-operative follow-up protocols and actions for their patients and ensure that patients are informed about symptoms (particularly pain and knee instability) that might indicate the need for implant review or revision surgery, and the need to seek follow up care should these symptoms arise.
For further information please see https://www.tga.gov.au/alert/genesis-ii-knee-system-non-porous-tibial-baseplate-used-knee-replacement. This action has been closed-out on 22/08/2016. |
| Contact Information |
02 9857 3999 - Smith & Nephew Surgical |