| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00757-3 |
| Product Name/Description |
NC and RC screw for Cares Abutment, Zr02 and IFU
NC Screw for CARES® Abutment, Zr02 and IFU; article 022.2630
RC Screw for CARES® Abutment, Zr02 and IFU; article 022.4630
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
A customer complaint reports that the article 022.2630 NC Screw for CARES® Abutment, Zr02 and IFU contains an incorrect screw. The investigation has confirmed that there has been a mix-up and a limited number of articles 022.2630 NC Screw for CARES® Abutment, Zr02 and IFU incorrectly contain an RC Screw and 022.4630 RC Screw for CARES® Abutment incorrectly contain an NC Screw. All of the affected lots are identified and stopped further shipment However the invesitgation indicates that these incorrect screws have been shipped in 9 cases 027.4650 CARES® Abutment Set RC, Ceramic and 87 cases 027.2650 CARES® Abutment Set NC, Ceramic and Dental Laboratory.
This recall action was not notified to the TGA before it was initiated by Straumann Pty Ltd. |
| Recall Action |
Recall |
| Recall Action Instructions |
Quarantine and return affected product to the distributors. |
| Contact Information |
1800 660 330 - Straumann Australia |