Events

Recall of SOFT TISSUE RETRACTOR

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
    27672
  • Event Risk Class
    II
  • Event Initiated Date
    2013-08-07
  • 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. is initiating a voluntary labelling recall related to the surgical technique guide "plate insertion instruments. for minimally invasive plate ostemynthesis (mipo)." this action has been initiated as a result of review for the previous recall of the soft tissue retractor small extendible (325.010) due to locking nut (clamping sleeve) malfunction. the revised surgical technique guides contains a precaution on page 3 stating "do not overtighten the clamping sleeve as this could lead to breakage". this labelling recall requires that customers review the new technique guides provided in this mailing and replace previous revisions with the revised copies.

Device

SOFT TISSUE RETRACTOR
  • Model / Serial
    Model Catalog: 325.010 (Lot serial: N/A)
  • Product Description
    SOFT TISSUE RETRACTOR
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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