Zirconia ceramic femoral head prostheses

Medical device recall - urgent hazard alert

23 August 2001 Revision: V1-1

Level:	Hospital	Class:	I
Reference:	R2001/233-239	Date:	16 August 2001
Product:	Zirconia Ceramic Femoral Head Prostheses
ARTG number:	AUST L (various)
Batch number:	Various
Sponsors:	Biomet Australia P/L DePuy Australia P/L Smith & Nephew Surgical P/L Stryker Australia P/L Taylor Bryant P/L Zimmer Australia P/L
Recall reason:	The Therapeutic Goods Administration has been notified of spontaneous disintegration of zirconia ceramic femoral head prostheses in some batches manufactured by Saint Gobain Ceramiques Avancees Desmarquest (France).
Recall letters have been despatched today, 16 August 2001. Manufacturer: Saint Gobain Ceramiques Avancees Desmarquest (France). Distribution: Australia wide. This recall arose following the TGA investigation of an overseas recall. This recall has been deemed to be safety-related.

Classification system:

Class I defects are potentially life-threatening or could cause a serious risk to health.

Class II defects could cause illness or mistreatment, but are not Class I.

Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.

Class I & II recalls are considered to be safety related recalls.