Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01359-1
Product Name/Description	Bending/Cutting Pliers with Nose, for LOCK Plates 2.0 Part Number: 329.143 Multiple Lot Numbers affected ARTG Number: 153950
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	23/12/2014
Responsible Entity	Synthes Australia Pty Ltd
Reason/Issue	The pliers have the potential for tip breakage while bending the extra-large Compact 2.0 Mandible Locking Plates (Part Numbers 447.412, 447.420, 447.422, 447.423, 447.424, 447.425, 447.426, 447.412S, 447.420S, 447.422S, 447.423S 447.424 S, 447.425 S and 447.426S ) with the last hole feature of the instrument. If a nonconforming Bending/Cutting Pliers with Nose for LOCK Plates 2.0 is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located. To date, there have been no reports of adverse events related to this issue. Such reports are unlikely to occur as the Bending/Cutting Pliers with Nose for LOCK Plates 2.0 are not used in direct contact with the patient but rather on the plates before they are inserted.
Recall Action	Recall
Recall Action Instructions	Customers are requested to:- 1. Check inventory immediately for the affected units; 2. Synthes will contact customers to arrange a replacement or credit as available; 3. An interim inspection procedure had been provided to customers whilst awaiting replacement stock. This action has been closed-out on 14/07/2016.
Contact Information	1800 796 8437 - Synthes Australia Pty Ltd