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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00733-1
Product Name/Description VEPTR Vertical Expandable Prosthetic Titanium Rib

Caudal Rib Supports (Rib-to-Rib Construct Only)

Multiple Lot Numbers

ARTG number: 160218
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 13/08/2015
Responsible Entity Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue This action is being initiated because the last hole on the VEPTR Caudal Rib Supports, subject to this recall, may be partially formed. Fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to extension bar breakage, which could require unplanned surgical intervention to exchange components. In addition to the risks inherent to re-operation, potential effects on the patient could also include pain, loss of deformity correction, and/or soft tissue/visceral injury.
Recall Action Recall
Recall Action Instructions Customers are asked to immediately check their inventory to determine if their facility has any affected product and to subsequently quarantine these units prior to returning them to JJM. This action has been closed-out on 29/08/2016.
Contact Information 1300 562 711 - Customer Service