Events

Recall of PFNA Nails (used during internal fixation surgery)

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

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-2015-RN-01266-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01266-2
  • 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
    It was discovered that the above part and lot numbers may have the incorrect anodised colour. an implant with the incorrect anodised colour would not cause harm to the patient. if the user identifies the nonconformity during surgery, marginal surgical delay may occur while an alternate implant is located.
  • Action
    JJM is advising users to inspect and quarantine affected stock for return to JJM. This action has been closed-out on 05/09/2016. This action has been closed-out on 05/09/2016.

Device

PFNA Nails (used during internal fixation surgery)
  • Model / Serial
    PFNA Nails (used during internal fixation surgery)PFNA ø10 125° L240 TAN Part Number: 472.260S, Lot Number: 7913867PFNA ø11 125° L240 TAN Part Number: 472.261S, Lot Number: 2812685PFNA ø10 long r 125° L340 TAN Part Number: 472.275S, Lot Number: 2806520ARTG Number: 161140
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes