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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00912-1
Product Name/Description	GENESIS II PS Articular Inserts (internal tibial component for knee prosthesis) GENESIS II PS Articular Insert Size 3-4 13mm Catalogue Number: 71420820 Lot Number: 12GT20824 GENESIS II PS High Flexion Insert Size 3-4 9mm Catalogue Number: 71421508 Lot Number: 12GT20822 ARTG Number: 114463
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	29/08/2013
Responsible Entity	Smith & Nephew Surgical Pty Ltd
Reason/Issue	The manufacturer has advised that the Tyvek lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. During a Total Knee Arthroplasty surgery, the user will most likely notice the inadequate seal and request another device.
Recall Action	Recall
Recall Action Instructions	Smith & Nephew is advising users to inspect products and quarantine affected devices. Affected devices will be replaced by Smith & Nephew.
Contact Information	02 9857 3999 - Smith & Nephew Surgical