Events

Recall of RESTORATION MODULAR HIP SYSTEM - POROUS HA STEM

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
    21781
  • Event Risk Class
    II
  • Event Initiated Date
    2010-01-13
  • 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 was aware of a labeling issue associated with the restoration modular plasma distal stem part # 6276-5-026 lot code # 20503201 and part # 6276-5-014 lot code # 20568201. the implant [part # 6276-5-026] was discovered with two different labels on the box. the box had the correct size #26 label at one end and a different size #14 label- part # 6276-5-014 lot code 20568201 at the other end. it was determined that there was a possibility that qty 1 of the size #14 may have a size #14 label at one end and a size #26 label at the other end.

Device

RESTORATION MODULAR HIP SYSTEM - POROUS HA STEM
  • Model / Serial
    Model Catalog: 6276-5-014 (Lot serial: 20568201)
  • Product Description
    RESTORATION MODULAR PLASMA DISTAL STEM
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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