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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 Smith & Nephew Pty Ltd
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