Events

Recall of 6.5MM CANNULATED SCREW

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
    60309
  • Event Risk Class
    III
  • Event Initiated Date
    2016-03-11
  • 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
    It was reported that affected labelling (technique guides j2455 and j3270) may contain information regarding the use of some cannulated cortex and cancellous screws that do not match the cleared indications for use in canada. all affected labelling will be corrected to include only the correct indications.

Device

6.5MM CANNULATED SCREW
  • Model / Serial
    Model Catalog: 208.404 (Lot serial: N/A); Model Catalog: 208.403 (Lot serial: N/A); Model Catalog: 208.402 (Lot serial: N/A); Model Catalog: 208.401 (Lot serial: N/A); Model Catalog: ALL PART NUMBERS (Lot serial: N/A); Model Catalog: 208.480-208.487 (Lot serial: N/A); Model Catalog: 208.47-208.479 (Lot serial: N/A); Model Catalog: 208.46-208.469 (Lot serial: N/A); Model Catalog: 208.455 (Lot serial: N/A); Model Catalog: 208.454 (Lot serial: N/A); Model Catalog: 208.453 (Lot serial: N/A); Model Catalog: 208.452 (Lot serial: N/A); Model Catalog: 208.451 (Lot serial: N/A); Model Catalog: 208.450 (Lot serial: N/A); Model Catalog: 208.448 (Lot serial: N/A); Model Catalog: 208.447 (Lot serial: N/A); Model Catalog: 208.446 (Lot serial: N/A); Model Catalog: 208.445 (Lot serial: N/A); Model Catalog: 208.444 (Lot serial: N/A); Model Catalog: 208.443 (Lot serial: N/A); Model Catalog: 208.442 (Lot serial: N/A); Model Catalog: 208.449 (Lot serial: N/A); Model Catalog: 208.441 (Lot serial: N/A); Model Catalog: 208.440 (Lo
  • Product Description
    6.5MM CANNULATED SCREW;CANNULATED SCREW;7.0MM CANNCELLOUS SCREW;4MM TI CANNULATED SCREW SHORT THREAD;4.5MM CANN SCREW PAR. THRD.;3.5/4.0 MM CANNULATED SCREW IMPLANT SET AND INSTRUMENTS;7.3MM CANNULATED SCREW;CORTEX SCREWS (PURE TITANIUM);6.5MM TITANIUM CA
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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