Events

Recall of DURACON ISA MOBILE BEARING KNEE TIBIAL INSERT

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
    109399
  • Event Risk Class
    II
  • Event Initiated Date
    2011-09-14
  • 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
    A packaging discrepancy was identified in specific lots of stryker's duration packaging. it was found that the outer blister container did not meet stryker's internal packaging specifications: specifically seal width and/or breach of the outer seal. each potentially affected duration packaging unit includes an inner and outer blister container. the inner blister was found intact and product sterility was not compromised.

Device

DURACON ISA MOBILE BEARING KNEE TIBIAL INSERT
  • Model / Serial
    Model Catalog: 6642-2-216 (Lot serial: ALL); Model Catalog: 6642-2-213 (Lot serial: ALL); Model Catalog: 6642-2-211 (Lot serial: ALL); Model Catalog: 6642-2-209 (Lot serial: ALL); Model Catalog: 6642-2-016 (Lot serial: ALL); Model Catalog: 6642-2-013 (Lot serial: ALL); Model Catalog: 6642-2-011 (Lot serial: ALL); Model Catalog: 6642-2-009 (Lot serial: ALL); Model Catalog: 6481-3-320 (Lot serial: ALL); Model Catalog: 6481-3-324 (Lot serial: ALL); Model Catalog: 6481-3-316 (Lot serial: ALL); Model Catalog: 6481-3-313 (Lot serial: ALL); Model Catalog: 6481-3-310 (Lot serial: ALL); Model Catalog: 6481-3-224 (Lot serial: ALL); Model Catalog: 6481-3-220 (Lot serial: ALL); Model Catalog: 6481-3-216 (Lot serial: ALL); Model Catalog: 6481-3-213 (Lot serial: ALL); Model Catalog: 6481-3-210 (Lot serial: ALL); Model Catalog: 6481-2-140 (Lot serial: ALL); Model Catalog: 6642-3-616 (Lot serial: ALL); Model Catalog: 6642-3-613 (Lot serial: ALL); Model Catalog: 6642-3-611 (Lot serial: ALL); Model Catalog: 6642-3-609 (Lot se
  • Product Description
    DURACON ISA MOBILE BEARING KNEE TIBIAL INSERT
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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