Events

Recall of LOOK NYLON SUTURES WITH NEEDLES

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

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
    152855
  • Event Risk Class
    II
  • Event Initiated Date
    2008-09-09
  • 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
    Approximately 4% of units of product labeled as 3-0 black mono nylon released to the field will contain 4-0 black braided silk suture. both products nylon and silk are indicated for use in general soft tissue approximation and/or ligation. however in the unlikely situation that silk is used during vascular anastomosisvascular tissue reaction could occur.

Device

LOOK NYLON SUTURES WITH NEEDLES

Manufacturer

SURGICAL SPECIALTIES CORPORATION