Print version of this report
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 Smith & Nephew Pty Ltd
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 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