Events

Recall of S-ROM TOTAL KNEE SYSTEM - NOILES ROTATING HINGE FEMORAL COMPONENT

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
    131993
  • Event Risk Class
    II
  • Event Initiated Date
    2014-03-03
  • 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
    Depuy orthopaedics is issuing a recall of the s-rom noiles rotating hinge femur with pin devices because it has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for both the femur and the hinge pin. the outer carton and shrink wrap are intact.

Device

S-ROM TOTAL KNEE SYSTEM - NOILES ROTATING HINGE FEMORAL COMPONENT
  • Model / Serial
    Model Catalog: 623401L (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 623411L (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 623411R (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 623421L (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 623421R (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 623401R (Lot serial: >100 NUMBERS CONTACT MFR)
  • Product Description
    S-ROM NOILES ROTATING HINGE FEMUR W/PIN
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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