| Level: | Hospital |
|---|---|
| Class: | I |
| Reference: | R2001/233-239 |
| Date agreed: | 16 August 2001 |
| Product: | Zirconia Ceramic Femoral Head Prostheses |
| ARTG number: | AUST L (various) |
| Batch number: | 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.
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.