| TGA Action ID |
RC-2026-RN-00343-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Implant Retrieval Instrument CC RP & Tri-Channel WP 22mm
Catalog number: 37475
Lot numbers: 76648, 76665, 76719 |
| ARTG Number |
523225 |
| Unique Device Identifier (UDI) |
07332747190625 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
The Implant Retrieval Instrument CC RP & Tri-Channel WP 22mm has been mixed up with an Implant Retrieval instrument intended for the wide platform (WP). The laser marking on the device (“CC RP”) is in line with the packaging, but not correct for the delivered article.
The affected Implant Retrieval Instrument does not function as intended. Since the connecting part of the instrument is too wide, it cannot be used to retrieve a CC RP or Tri-Channel WP implant.
The main harm that could occur is that the implant retrieval surgery needs to be delayed and completed at a later time.
There have been two customer complaints associated with this problem, no patient harm has been reported. |
| Instructions for Customers/Users |
Customers are to:
- Inspect stock and quarantine affected devices.
- Complete the Customer Acknowledgment Form.
- Return all affected stock on hand using the shipping label provided by Nobel Biocare.
Nobel Biocare will replace affected devices. |
| Action Commencement Date |
11/05/2026 |
| Responsible Entity |
|
| Contact Information |
order.australia@nobelbiocare.com - Nobel Biocare |