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Zirconia ceramic femoral head prostheses
Medical device recall
|Date agreed:||16 August 2001|
|Product:||Zirconia Ceramic Femoral Head Prostheses|
|ARTG number:||AUST L (various)|
|Sponsor:||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
|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.
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.