| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00872-1 |
| Product Name/Description |
Thin and Radial Osteotome Blades
Multiple Products and Model Numbers
Multiple Batch Numbers
ARTG Number: 140704 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Smith & Nephew has identified a labelling error with specific models and batches of thin and radial Osteotome Blades. The expiration dates on the label exceed the actual validated expiration date of the outer sterile barrier packaging.
Affected devices have expiration dates based on a 10 year packaging shelf-life where the actual validated shelf life of the outer pouch packaging is 5 years. This could potentially result in the outside of the inner tray packaging being non-sterile, potentially contaminating the sterile field.
The inner tray packaging is validated for a 10 year shelf-life and to date no adverse events have been associated with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Smith & Nephew is requesting customers:
1. Immediately locate and quarantine affected devices;
2. If any of the recalled products could have been transferred from their hospital to another hospital please provide copies of the recall notice to all users;
3. The supplied acknowledgement form may be returned by email to RegulatoryAffairs.ANZ@smith-nephew.com or by fax on 1800 671 000 (Toll Free)
4. If you have affected product to return, Smith & Nephew representatives will be in contact with customers once the Recall Acknowledgement Form has been received to arrange for affected products to be returned. Please keep a copy of the completed Recall Acknowledgement form with any affected stock to be returned; and
5. Replacement products will be arranged once Smith & Nephew receive the Recall Acknowledgement Form.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9857 3908 - Smith & Nephew |