| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00276-1 |
| Product Name/Description |
Angular Stable Locking System (ASLS), 5.0 mm, Resorbable (Used with Synthes cannulated titanium intramedullary nails)
Part Number: 08.025.044.01S
Lot Number: 8586243
ARTG Number: 168395 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
The label of affected product lists the incorrect sterilisation and expiration date.
Incorrect Expiration Date listed on label: 2018-06
Actual Expiration Date: 2017-07
Incorrect Sterilisation Date listed on label: 2014-06
Actual Sterilisation Date: 2013-10
If the affected lot number were to be used past the expiration date of July 2017, malunion/non-union may occur. |
| Recall Action |
Recall |
| Recall Action Instructions |
Johnson & Johnson Medical Pty Limited (JJM) is advising customers that they can return the affected stock if they choose to do so. This action has been closed-out on 02/06/2016. |
| Contact Information |
02 9815 4000 - Johnson & Johnson Medical |