| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00925-1 |
| Product Name/Description |
D-Rad Titanium 2.4mm x 10mm Locking Screw T7 Self-Tapping
Model Number: 74692412
Batch Number: 15JM07539
Expiry: September 2017
ARTG Number: 104369 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Smith & Nephew has identified that a number of devices are affected due to a labelling error. The expiration dates printed on the labels are incorrect; the dates shown are after the actual expiration date of the sterilised package. |
| 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 your facility to another hospital, provide copies of this notice to all users informing them of the recall;
3.Complete,sign and return the supplied Recall Acknowledgement Form with the number of affected devices you have to return. Complete the form even if you have no products to return.
4.The acknowledgement form may be returned by email to RegulatoryAffairs.ANZ@smith-nephew.com or by fax on 1800 671 000 (Toll Free)
5.If you have affected product to return, Smith & Nephew representatives will be in contact with you once you have returned the Acknowledgement Form to arrange for affected products to be returned.
6.New unaffected replacement devices will be provided to you once Smith & Nephew have received your response.
This action has been closed out on the 11/10/2018. |
| Contact Information |
02 9857 3918 - Smith & Nephew |