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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00358-1
Product Name/Description Connecting Screw for Insertion of Dynamic Hip Screw (DHS) Blade
(Component of the fixation system implantation kit)

Part Number: 03.224.007

Lot Numbers:
2161305, 2290282, 2523116, 2684005, 7799873, 8296913, 8586241, 9001624, 2243635, 2290283, 2557362, 2733243, 7799873, 8465206, 8694982, 9290024, 2260851, 2512219, 2561953, 2762808, 8037035, 8487190, 8759606, 2260851-I, 2290278, 2513675, 2630618, 2800137, 8117808, 8577396, 8889838, 2260851-L.

ARTG number: 153950
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 23/04/2015
Responsible Entity Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue Complaints of the insertion screw breaking inside the blade implant during insertion. When the DHS Blade Connecting Screw breaks inside the implant, it blocks the locking mechanism that is important for rotational stability (ensuring the bone fragments maintain anatomical reduction). In the event that the tip of the Connecting Screw breaks intraoperatively, the implant locking mechanism (for rotational stability) cannot be secured.

If the fragment cannot be retrieved, rotational stability is compromised and the blade needs to be replaced or additional lag screws implanted. This may lead to prolongation of surgical operating time, bone damage and subsequent interventions such as a total hip arthroplasty. If the fragment cannot be retrieved and remains in the DHS Blade in the patient, this could lead to an adverse tissue reaction since the Connecting Screw is not made of implant grade stainless steel.
Recall Action Recall
Recall Action Instructions Johnson & Johnson Medical Pty Limited (JJM) is requesting the customers to check the inventory and quarantine the affected stock prior to returning it to JJM. This action has been closed-out on 24/08/2016.
Contact Information 1800 252 194 - Johnson & Johnson Medical