| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01023-1 |
| Product Name/Description |
Atlantis Abutment in Ti - Straumann Bone Level 3.3 NC
Case Number: 102796083
This product is not included on the ARTG |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
24/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
A production issue has resulted in a small number of Atlantis abutments being manufactured not in accordance with specifications.
Due to the error it is likely that the abutment will not be able to seat in the implant and the abutment screw will not engage. |
| Recall Action |
Recall |
| Recall Action Instructions |
The customer is to quarantine that affected product to prevent further use.
A remake will be provided to the customer. |
| Contact Information |
1300 552 929 - Australian customer service |