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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00723-1
Product Name/Description	DePuy Synthes Socket, Hexagonal Ø 4.0mm/11.0mm. Part Number: 356.714 – All lots ARTG Number: 153950
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	7/08/2015
Responsible Entity	Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue	Johnson & Johnson Medical Pty. Ltd. (JJM) is issuing a recall for ALL lots of the DePuy Synthes Socket, Hexagonal Ø 4.0mm/11.0mm. The Socket is a cannulated instrument used to insert the end caps in the Proximal Femoral Nail Anti-rotation (PFNA), PFNA-II, and the Antegrade Femoral Nail (AFN). There is a potential for the Socket-hex tip to break into fragments during use if too much force is applied. As the affected item has been reported to break intra-operatively, there is potential for surgical delay while the fragments are retrieved. Consequently, surgical delay may occur while a replacement instrument or alternative device is located to insert the end cap. In addition, an adverse tissue reaction may possibly occur if any stainless steel fragments from the Socket are not retrieved from the patient.
Recall Action	Recall
Recall Action Instructions	JJM is requesting their customers to immediately check their inventory to determine if their facility has any affected product. If affected stock is identified quarantine prior to organising its return to JJM. This action has been closed out on the 24/09/2018.
Contact Information	1300 562 711 - Customer Service