| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01518-1 |
| Product Name/Description |
BIOLOX delta ceramic components
Biolox Delta Modular Head and Trinity Ceramic Liner
All Part Number / Lot Codes
ARTG Numbers: 211371 and 210774 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Data from sources external to Corin suggest that ceramic fragments from fractured ceramic components may remain in the joint following revision surgery, which can lead to premature wear of revision components if such revision components are made of non-ceramic materials. As a result, the instruction within the IFU for Corin’s Biolox delta ceramic components have been updated in respect of recommended actions in the case of revisions. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The IFU is being revised to include the following information in the ‘Warnings & Precautions’ section:
In the case of revision due to a fractured ceramic component, when keeping a well fixed stem, the modular head must be replaced with a Biolox Option modular head where available. If a Biolox Option modular head is not available, in addition to revising the modular head, the femoral stem must also be revised to provide a suitable taper to which a new ceramic femoral ball head can be attached. In the event of revision not due to fracture of a ceramic component, when keeping a well fixed stem, the modular head must be replaced with a metal modular head or a Biolox Option ceramic modular head only.
This action has been closed out on the 12/11/2018. |
| Contact Information |
02 9497 7432 - Corin Australia |