Events

Recall of GRAPHIC CASES FOR 6.5MM & 7.3MM CANNULATED SCREW SETS

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
    94209
  • Event Risk Class
    III
  • Event Initiated Date
    2018-03-08
  • 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 synthes is conducting a lot-specific recall of the graphic cases for 6.5mm and 7.3mm cannulated screw sets because they contain screw gauges that incorrectly measure screws 5.41mm shorter than the actual overall screw length. thus when using the measuring gauge the surgeon would potentially be inserting a screw which is 5.41mm shorter than intended.

Device

GRAPHIC CASES FOR 6.5MM & 7.3MM CANNULATED SCREW SETS
  • Model / Serial
    Model Catalog: 690.379-US (Lot serial: H340372); Model Catalog: 690.375-US (Lot serial: H340372); Model Catalog: 690.380-US (Lot serial: FL00860); Model Catalog: 690.379-US (Lot serial: FL00860); Model Catalog: 690.380-US (Lot serial: H340372); Model Catalog: 690.375-US (Lot serial: FL00860)
  • Product Description
    GRAPHIC CASES FOR 6.5MM & 7.3MM CANNULATED SCREW SETS
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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