Events

Recall of Bending/Cutting Pliers with Nose, for LOCK Plates 2.0

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Synthes Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2014-RN-01359-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01359-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

Bending/Cutting Pliers with Nose, for LOCK Plates 2.0
  • Model / Serial
    Bending/Cutting Pliers with Nose, for LOCK Plates 2.0 Part Number: 329.143 Multiple Lot Numbers affectedARTG Number: 153950
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd