Events

Recall of HOFFMANN LRF-HINGE COUPLING

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
    31778
  • Event Risk Class
    III
  • Event Initiated Date
    2018-03-05
  • 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 has become aware that some of the hinge coupling packaging may contain incorrect product. this issue was first discovered via customer complaint november 17 2017 where it was reported that upon opening the 4933-0-800 [lot# 23745] it was discovered that the packaging contained product # 4933-1-011 [lot# 19865]. this pfa applies to all unopened/originally packaged product.

Device

HOFFMANN LRF-HINGE COUPLING
  • Model / Serial
    Model Catalog: 4933-0-800 (Lot serial: L23745)
  • Product Description
    HOFFMANN LRF-HINGE COUPLING
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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