| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01176-1 |
| Product Name/Description |
Replace Select Tapered TiU RP 4.6x16mm (fully imbedded dental implant)
Product Number: 29415
Lot Number: 748046
ARTG Number: 97386
|
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
23/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
Nobel Biocare Australia's quality management systems have detected that some implants from the affected lot number of the Replace Select Tapered TiU RP 4.3x16mm implant may not have been machined correctly, causing the implant driver not to be able to engage the implant. There is no expected risk as the device cannot be implanted if the defect is present. |
| Recall Action |
Recall |
| Recall Action Instructions |
Quarantine and return affected products for replacement stock. |
| Contact Information |
1800 804 597 - Nobel Biocare Customer Service |