Events

Recall of HOWMEDICA MODULAR RESECTION SYSTEM - PROXIMAL TIBIA

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
    40014
  • Event Risk Class
    III
  • Event Initiated Date
    2010-04-19
  • 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 has become aware of an increased trend in the frequency of hmrs stem fractures which occur most often between the collar and the first screw hole on the stem. the fractures occurred when the anchorage stem was used in either the distal femur proximal femur or the proximal tibia. the anchorage stem can be used in either a fixed hinge or a rotating hinge knee construct. the root cause of this issue is that the labeling on the product is inadequate to preclude inappropriate patient selection for the device design.

Device

HOWMEDICA MODULAR RESECTION SYSTEM - PROXIMAL TIBIA
  • Model / Serial
    Model Catalog: 6367-4-013 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-012 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-011 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-019 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-017 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-112 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-015 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-014 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-013 (Lot serial: all lot/serial numbers); Model Catalog: 6365-5-012 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-115 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-114 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-113 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-111 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-014 (Lot serial: all lot/serial numbers); Model Catalog: 6367-4-015 (Lot serial: all lot/serial numbers);
  • Product Description
    Stryker HMRS Anchorage Pieces
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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