Events

Recall of PRESSFT SUTURE ANCHOR WITH HI-FI SUTURE

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

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
    48937
  • Event Risk Class
    II
  • Event Initiated Date
    2012-06-28
  • 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
    There is a remote possibility that the distal driver tip may become dislodged from the driver shaft if the instructions for use are not followed. lateral loading during insertion or extraction as contraindicated may cause a separation of the distal tip and driver shaft after successful insertion of the implant.

Device

PRESSFT SUTURE ANCHOR WITH HI-FI SUTURE
  • Model / Serial
    Model Catalog: NP211 (Lot serial: ALL); Model Catalog: NP212 (Lot serial: ALL); Model Catalog: NP211H (Lot serial: ALL); Model Catalog: NP261 (Lot serial: ALL); Model Catalog: NP261H (Lot serial: ALL); Model Catalog: NP262 (Lot serial: ALL)
  • Product Description
    PRESSFT SUTURE ANCHOR WITH HI-FI SUTURE
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    HC