| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00724-1 |
| Product Name/Description |
Dental Abutments ASC-EX-34 and ASC-EX-40
Batch/Lot/Serial Numbers: 275T01 & 036U02
Expiry: 2028
ARTG 450726
(Southern Implants Australia Pty Ltd - Dental implant suprastructure device, permanent) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
The ASC-EX-34 and ASC-EX-40 abutment screws have been designed too long and therefore bottom out and do not seat when used with certain dental implants.
Although the abutments are compatible with majority of dental implants, these abutments may be placed in Co-Axis implants that have a shorter internal screw hold and will not be able to be placed. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should:
1. Inspect their stock and quarantine affected devices to prevent further use.
2. Return affected stock on hand with the completed response form in the customer letter.
3. If affected devices have been used on regular implants the abutments will function as intended and no further action is required.
4. TIB-EX-34/40 or SIB-EX-34/40 or TC-EX-34/40 is a suitable alternative which is currently available for order. Customers can contact Southern Implants to arrange for replacement.
NB: The ASC-EX-34/40 is expected to be available from Southern Implants (Pty) Ltd by end of October 2024 and will be available for order. |
| Contact Information |
0400 159 067 - Bruce McDowell |