| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00650-1 |
| Product Name/Description |
BioHorizons 3.00mm Implant Analog
Product Code: TP3IA
Lot Numbers: 2304337, 2306786, 2304857
ARTG 439491
(Henry Schein Halas - Dental implant analog) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
1/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
A physical examination of the product has found that the external flats are indexed incorrectly (parallel) to the internal hex flats. With incorrect indexing the 3.0mm Implant Analog will not function properly if placed in a digitally printed model. The Analog will still function as intended if used in a traditional stone model workflow.
This problem does not affect any other lots of TP3IA or any other BioHorizons products.
The non-conforming condition does not represent a hazard to patient safety and no special patient remediation measures or other actions need to be taken. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should
1. Inspect stock for affected lot numbers and quarantine units to prevent further use.
2. Provide evidence of destruction or return affected stock on hand per the instructions provided in the Customer Letter.
Henry Schein Halas will provide a credit for affected stock. |
| Contact Information |
0409 790 316 - Kellie Paull, National Business Unit Manager |