| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01124-1 |
| Product Name/Description |
BioPlant Curved Syringe, multiple doses, BioPlant Intro Pack (synthetic dental bone grafts)
BioPlant Curved Syringe 0.125g
Part Number: 216110
BioPlant Curved Syringe 0.25g
Part Number: 216112
BioPlant Curved Syringe 0.50g
Part Number: 216114
BioPlant Curved Syringe 0.25g (2 pack)
Part Number; 216132
BioPlant Intro Pack
Part Number: 216112B
(Synthetic dental bone grafts)
All production lots within shelf life
ARTG Number: 121686 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
It has come to the attention of Kerr Australia that disturbing the BioPlant product soon after it is placed may halt or delay the ossification process. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Update to Instructions for Use (IFU). |
| Contact Information |
1800 643 603 - Kerr Australia Customer Care |