| 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 |
|
| 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 |