Events

Recall of PKR TIBIAL & FEMORAL TRIALS TRAY (UPPER)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STRYKER CANADA LP.

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
    41089
  • Event Risk Class
    III
  • Event Initiated Date
    2012-10-15
  • 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
    Stryker orthopaedics has received a report from the field indicating that a single pkr tibial & femoral trials tray (upper) (cat. no. 5650-8-002 lot km6lde) exhibited a size 4 insert trial bracket in the size 6 bracket location.

Device

PKR TIBIAL & FEMORAL TRIALS TRAY (UPPER)
  • Model / Serial
    Model Catalog: 5650-8-002 (Lot serial: KM6LDE)
  • Product Description
    PKR TIBIAL & FEMORAL TRIALS TRAY (UPPER)
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC