Events

Recall of TI CANNULATED HUMERAL NAIL SYSTEM STERILE

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
    28029
  • Event Risk Class
    II
  • Event Initiated Date
    2013-06-17
  • 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 (canada) ltd. received notification from its supplier synthes usa that a medical device recall was being initiated due to a reported complaint that during a humeral nail procedure the surgeon elected to implant a 3 distal locking hole nail. the operating room personnel selected the humeral nail which had a generic depiction of a 3 distal locking hole nail labelled. after opening the package it was discovered that the nail was a 2 distal locking hole nail. no patient injury or complication reported.

Device

TI CANNULATED HUMERAL NAIL SYSTEM STERILE
  • Model / Serial
    Model Catalog: 04.001.636S (Lot serial: 7115141); Model Catalog: 04.001.620S (Lot serial: 7119716); Model Catalog: 04.001.636S (Lot serial: 7119716); Model Catalog: 04.001.620S (Lot serial: 7115141)
  • Product Description
    TI CANNULATED HUMERAL NAIL SYSTEM STERILE
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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