Events

Recall of ADVANCE TOTAL KNEE SYSTEM - TIBIAL AUGMENTS (15 AND 25 DEGREE WEDGE)

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

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
    29677
  • Event Risk Class
    II
  • Event Initiated Date
    2010-02-11
  • 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
    Packages from two lots of advance tibial augments catalog # ktagw315 incorrectly contain 15mm length screws instead of the correct 5mm length screws. these products are assembled on the back table during the surgical procedure when the augment is attached to the tibial base by use of the screws provided. the incorrect length screws can be easily noted during the assembly process.

Device

ADVANCE TOTAL KNEE SYSTEM - TIBIAL AUGMENTS (15 AND 25 DEGREE WEDGE)
  • Model / Serial
    Model Catalog: KTAGW115 TO KTAGW625 (Lot serial: 087441267); Model Catalog: KTAGW115 TO KTAGW625 (Lot serial: 097441268)
  • Product Description
    ADVANCE TIBIAL WEDGE AUGMENT
  • Manufacturer
    WRIGHT MEDICAL TECHNOLOGY CANADA LTD

Manufacturer

WRIGHT MEDICAL TECHNOLOGY CANADA LTD