Events

Recall of NAIL WRAP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SYNTHES (CANADA) 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
    140303
  • Event Risk Class
    II
  • Event Initiated Date
    2015-07-31
  • 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
    Synthes has verified the wrap for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item. the decision to recall was made to address the potential for multiple use of the wrap.

Device

NAIL WRAP
  • Model / Serial
    Model Catalog: 900.50 (Lot serial: ALL LOTS); Model Catalog: 900.51 (Lot serial: ALL LOTS)
  • Product Description
    NAIL WRAP
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

SYNTHES (CANADA) LTD.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    HC