Events

Recall of RESTORATION MODULAR CONE BODY TRIALS

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
    32708
  • Event Risk Class
    III
  • Event Initiated Date
    2012-04-19
  • 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 orthopedics has become aware that there is the potential for the presence of a burr in the last threaded feature of restoration modular cone body trials. this threaded feature mates with the trial locking bolt. to date no product experience reports have been received with regard to this issue.

Device

RESTORATION MODULAR CONE BODY TRIALS
  • Model / Serial
    Model Catalog: 6278-1-329 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-337 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-325 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-323 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-321 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-319 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-231 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-229 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-227 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-225 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-223 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-221 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-219 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-131 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-129 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6278-1-127 (Lot serial: >10 NUMBE
  • Product Description
    RESTORATION MODULAR CONE BODY TRIALS
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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