Events

Recall of ORTHOCORD SUTURE WITH NEEDLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC..

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
    140043
  • Event Risk Class
    III
  • Event Initiated Date
    2013-03-27
  • 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 field correction is being distributed to inform customers that orthocord sutures with blue codes are expected to retain 80% of their original strength at six weeks after implantation instead of the 100% figure that appears in the current instructions for use (ifu).

Device

ORTHOCORD SUTURE WITH NEEDLE
  • Model / Serial
    Model Catalog: 223116 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 223115 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 223114 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 223111 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 223113 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    BLUE FREE STRAND ORTHOCORD SUTURES
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.