| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01035-1 |
| Product Name/Description |
Whipknot Soft Tissue Cinch #5 Sutures (used in assisting in the harvest, preparation, and placement of soft tissue grafts during ligament reconstructive surgery)
Product Number: 7211015
Multiple Batch Numbers
ARTG number: 99843 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Several batches of Whipknot Soft Tissue Cinch #5 Sutures have a potential packaging issue. A Smith & Nephew internal evaluation revealed that the packaging design is insufficient to prevent a potential sterile barrier breach (pin hole) in the Tyvek film of the pouch.
If the sterile barrier breach is not detected prior to use, the compromised packaging could potentially lead to a non-sterile device entering the surgical field.
To date, there have been no complaints or adverse events associated with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Smith & Nephew is advising users to immediately locate and quarantine affected devices. Affected stock will be replaced with unaffected product.
This action has been closed out on the 26/10/2018. |
| Contact Information |
02 9857 3918 - Smith & Nephew |