Events

Recall of PANTA ANKLE NAIL SYSTEM - NAIL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NEWDEAL SAS.

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
    22952
  • Event Risk Class
    II
  • Event Initiated Date
    2013-05-24
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Integra has become aware of incidents attribuable to the surgical technique of the panta arthodesis nail system manufactured by newdeal sas. the incidents are due to a misalignment of the calcaneal or tibial screws and the panta arthrodesis nail with or without clinical consequences during the panta arthrodesis nail surgery.

Device

PANTA ANKLE NAIL SYSTEM - NAIL
  • Model / Serial
    Model Catalog: 500 080 (Lot serial: All batches); Model Catalog: 500 380 (Lot serial: All batches); Model Catalog: 500 350 (Lot serial: All batches); Model Catalog: 500 280 (Lot serial: All batches); Model Catalog: 500 050 (Lot serial: All batches); Model Catalog: 500 180 (Lot serial: All batches); Model Catalog: 500 150 (Lot serial: All batches); Model Catalog: 500 250 (Lot serial: All batches)
  • Product Description
    PANTA ANKLE NAIL SYSTEM - NAIL
  • Manufacturer
    NEWDEAL SAS

Manufacturer

NEWDEAL SAS