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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 Smith & Nephew Pty Ltd
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