Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01211-1
Product Name/Description PFN/PFNA Insertion Handle (used for the insertion of Proximal Femur Nail during internal fixation surgery)

Versions 1, 3.1 and 3.2

Part Number: 357.012

Multiple Lot Numbers affected

ARTG Number: 153950
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 10/12/2015
Responsible Entity Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue Johnson & Johnson Medical Pty. Ltd. (JJM) is issuing a recall for specific lots of Versions 1, 3.1 & 3.2 of the PFN / PFNA Insertion Handle. The PFN/PFNA Insertion Handle is made to insert PFN / PFNA / PFNAII / PFNA augmented nails. The insertion handle may break when struck with a hammer during the nail insertion process.
Recall Action Recall
Recall Action Instructions JJM is advising users to inspect stock quarantine affected units for return to JJM.
This action has been closed-out on 07/09/2018.
Contact Information 1300 562 711 - JJM Customer Service