| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01544-1 |
| Product Name/Description |
Biolox Delta Ceramic Hip Components
Biolox Delta Ceramic Femoral Head
ARTG Number: 218138
R3 Biolox Delta Ceramic Liner
ARTG Number: 218185
EP-FIT Biolox Delta Ceramic Insert
ARTG Number: 222565 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Smith & Nephew is issuing this notification in relation to the ongoing use of all Ceramic Hip Prostheses, including femoral ball heads and acetabular cup (shell) liners/ inserts that are either manufactured or distributed globally by Smith & Nephew. Recent post-market surveillance suggests that ceramic fragments from fractured ceramic components of hip prostheses may remain in the joint during revision surgery, which may lead to premature wear in revision components if such revision components are made of non-ceramic materials. This may lead to a need for an additional revision surgery. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
This notification has been issued by Smith & Nephew to caution against the use of non-ceramic components when revising fractured ceramic components used in hip arthroplasty and inform surgeons of changes to the warnings in Smith & Nephew Instructions for use (IFU). Additional information is provided in the letter to surgeons and the revised IFU.
This action has been closed out on the 12/11/2018. |
| Contact Information |
02 9857 3908 - Smith & Nephew |