Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00216-1
Product Name/Description Aiming Arm 125deg and Aiming Arm 130deg for TFN-ADVANCED (TFNA) System

(Orthopaedic surgical guide)

ARTG: 153950
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 16/03/2015
Responsible Entity Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue It was discovered that during blade insertion, the TFNA Guide Sleeve has the potential to jam inside of the affected Aiming Arms which may delay disassembly and/or removal of the instruments.
Recall Action Recall
Recall Action Instructions Johnson & Johnson Pty Limited is providing end users with work around instructions to be used until replacement stock is available. In the event that the user has difficulty with the Aiming Arm/Guide Sleeve Assembly the user can disassemble via two methods:
1) Turn the Guide Sleeve counter clockwise within the Aiming Arm to clear the jamming. This operation can be performed manually and requires relatively low force and no additional instrumentation.
2) Disassemble the Aiming Arm/Guide Sleeve assembly as one unit by disengaging the Aiming Arm coupling screw from the Insertion Handle. The instruments can then be disassembled for cleaning using the technique described in 1).

Johnson & Johnson Pty Limited will provide replacement product by 1 May 2015. This action has been closed-out on 17/08/2016.
Contact Information 02 9815 4000 - Johnson & Johnson Medical