| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01212-1 |
| Product Name/Description |
Drill set long, drill stop compatible for D 4.8mm Implant
Article number: 040.447S
Lot numbers: GY037, HA443, HE874, HL216 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Institut Straumann has received a customer complaint reporting that 040.447S Drill set long, drill stop compatible for D 4.8mm Implant lot GY037 contains a green colour coded drill which is incorrectly D3.5mm instead of D4.2mm. The investigation of this complaint has confirmed that the green colour coded drill is only D3.5mm. All other drills within the set 040.477s Drill set long, drill stop compatible for D 4.8mm Implant are correct. The investigation determined that there are potentially two further Drill Sets 040.447S that contain an incorrect drill (D3.5mm / green colour coding) and that these Drills sets are in one of the listed lot numbers. This issue is limited to article number 040.447S lot numbers GY037, HA443, HE874, HL216 only.
This action was undertaken prior to the notification to the TGA. |
| Recall Action |
Recall |
| Recall Action Instructions |
Straumann Australia requested the customers to check their inventory and if the article 040.447S Drill set long, drill stop compatible for D 4.8mm Implant Lot HA443 is still in your inventory, please return it to Straumann Australia for credit or replacement.
This action was undertaken prior to the notification to the TGA. This action has been closed-out on 05/09/2018. |
| Contact Information |
Straumann Australia 1800 660 330 |