Events

Recall of SOLIS TRIAL CAGE

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
    65179
  • Event Risk Class
    III
  • Event Initiated Date
    2011-11-07
  • 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
    It was detected in qc control that the hole used to thread the solis trial onto the implant holder was manufactured on the left side of the instrument instead of the right as indicated on the engineering print. this leads to the trial being placed upside down on the handle. the implant handle has markings indicating the cranial and caudal sides on the top and bottom respectively. the nonconforming trials result in the cranial side of the trial being inserted facing caudal.

Device

SOLIS TRIAL CAGE
  • Model / Serial
    Model Catalog: 8741207 (Lot serial: 10G757); Model Catalog: 8741207 (Lot serial: 08C688); Model Catalog: 8741406 (Lot serial: 08C688); Model Catalog: 8741404 (Lot serial: 08C688); Model Catalog: 8741209 (Lot serial: 08C688); Model Catalog: 8741206 (Lot serial: 08C688); Model Catalog: 8741207 (Lot serial: 10F956); Model Catalog: 8741406 (Lot serial: 10F956); Model Catalog: 8741404 (Lot serial: 10F956); Model Catalog: 8741209 (Lot serial: 10F956); Model Catalog: 8741206 (Lot serial: 10F956); Model Catalog: 8741206 (Lot serial: 91854); Model Catalog: 8741406 (Lot serial: 10G757); Model Catalog: 8741404 (Lot serial: 10G757); Model Catalog: 8741209 (Lot serial: 10G757); Model Catalog: 8741206 (Lot serial: 10G757); Model Catalog: 8741207 (Lot serial: 10G655); Model Catalog: 8741406 (Lot serial: 10G655); Model Catalog: 8741404 (Lot serial: 10G655); Model Catalog: 8741209 (Lot serial: 10G655); Model Catalog: 8741206 (Lot serial: 10G655); Model Catalog: 8741207 (Lot serial: 91854); Model Catalog: 8741406 (Lot serial:
  • Product Description
    SOLIS TRIAL CAGE
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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