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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00418-1
Product Name/Description CHISEL BLADES
(used in conjunction with the conventional chisel handle (part 399.540) to cut and shape bone during orthopedic surgery)

Chisel Blade, long, width 10 mm
P/N: 399.555
Lot numbers: A7OA30, T921923, T933948 & 935423

Chisel Blade, long, width 16 mm
P/N: 399.565
Lot numbers: A7QA37 & T936951

Chisel Blade, long, width 25 mm
P/N: 399.575
Lot numbers: A7OA36, T937762 & T966630

P/N: 399.585
Lot numbers: A7OA30 & T939691

ARTG number: 153950
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 18/05/2015
Responsible Entity Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue The incorrect label was applied to the product that is the subject of this action. Certain lots of the Chisel Blades that were shipped to your facility may be labeled as “NOT FOR HUMAN USE; FOR VETERINARY USE ONLY”
Recall Action Recall
Recall Action Instructions The incorrect label was applied to the product that is the subject of this action. Certain lots of the Chisel Blades that were supplied may be labelled as “NOT FOR HUMAN USE; FOR VETERINARY USE ONLY” This action has been closed-out on 03/03/2016.
Contact Information 1800 796 843 - DePuy Synthes customer service