Events

Recall of TRIATHLON TIBIAL ALIGNMENT HANDLE

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
    45981
  • Event Risk Class
    II
  • Event Initiated Date
    2011-10-12
  • 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 received a product experience report (per) that a swivel block was improperly oriented on a triathlon tibial alignment handle. the locator holes on the alignment guide handle on which the swivel block is mounted are not in alignment as per print. the tibial alignment handle was not machined properly on the 5 axis machine because the tibial alignment handle was not fixtured properly on the machine by the operator. the fixturing procedure involved manually locating every part in a collet aligning datum c using a square and locking the part in position for machining of the slot and cross hole. additionally the particular feature was not inspected during in-process and/or final inspection at the vendor. hence the non-conformance was not detected.

Device

TRIATHLON TIBIAL ALIGNMENT HANDLE
  • Model / Serial
    Model Catalog: I-K2072AHOO (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6541-2-807 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6541-2-808 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    TRIATHLON TIBIAL ALIGNMENT HANDLE
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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