Events

Recall of MEDULLARY REAMER HEAD

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
    36081
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-23
  • 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
    This recall is being initiated due to the supplier reporting the possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material.

Device

MEDULLARY REAMER HEAD
  • Model / Serial
    Model Catalog: 352.085 (Lot serial: 15932 through 19396); Model Catalog: 352.085 (Lot serial: 20141 through 24510); Model Catalog: 352.085 (Lot serial: 1448284 through 2087630); Model Catalog: 352.085 (Lot serial: 24613 through 25347); Model Catalog: 352.085 (Lot serial: 4399543 through 5870257)
  • Product Description
    MEDULLARY REAMER HEAD
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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