| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00735-1 |
| Product Name/Description |
LPS (Limb Preservation System) Lower Extremity Dovetail Intercalary Component (internal femoral component)
Part Number: 1987-19-055
All lot numbers are affected
ARTG Number: 131657 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
30/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
The LPS Lower Extremity Dovetail Intercalary component has the potential for the female component to fracture when exposed to certain physiological loads. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Johnson & Johnson Medical is not recommending prophylactic treatment in the absence of symptoms. Surgeons are recommended to review each patient’s case to determine the best treatment options, considering the patient’s weight, activity level and/or any other potential contributing factors.
If a patient presents with a fractured LPS Lower Extremity Dovetail Intercalary component with well-fixed proximal and distal stems and the surgeon determines that the LPS Lower Extremity Dovetail Intercalary component is the best treatment option, the company will make the LPS Lower Extremity Dovetail Intercalary component available. For more details, please see http://www.tga.gov.au/safety/alerts-device-limb-preservation-system-130805.htm . |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical |