Product description
Manufactured by Saint Gobain Ceramiques Avancees Desmarquest, France.
See a list of details to help identify the product
Reason the product is recalled
Possible rupture of zirconia ceramic femoral head prostheses in some batches manufactured by Saint Gobain Ceramiques Avancees Desmarquest, France.
The hazards to consumers
Component failure.
What consumers should do
Orthopaedic surgeons are contacting their patients advising they seek urgent medical attention should they be concerned that there has been a sudden change in their replaced hip.
Details to help identify the product
Supplier running the recall
Smith & Nephew Surgical Pty Ltd
Where the product was sold
Nationally
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2001/4888 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.