Events

Recall of OTISMED SHAPEMATCH CUTTING GUIDE

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
    88737
  • Event Risk Class
    I
  • Event Initiated Date
    2013-04-15
  • 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 orthopaedics is placing the otismed shape match cutting guides on hold to investigate product experience reports. the product will be on hold until the investigation is complete. at this time a product field action will be initiated to inform all surgeons registered on the otismed.Net website and all imaging centers to refrain from prescribing or performing mri or ct arthrogram for use with otismed shape match cutting guides while the investigation continues.

Device

OTISMED SHAPEMATCH CUTTING GUIDE
  • Model / Serial
    Model Catalog: TR3100-L (Lot serial: ALL); Model Catalog: TR3100-R (Lot serial: ALL)
  • Product Classification
    Orthopedic Devices
  • Product Description
    OTISMED SHAPEMATCH CUTTING GUIDE
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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