Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Stryker Howmedica Osteonics Corp.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 001 08 11 000
  • Event Initiated Date
    2011-08-01
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=710
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Reason
    (1) due to the presence of excessive material at the base of the slot feature in the distal femoral component as observed on the returned per device; and, (2) due to the circlip slot position being incorrect for both the hmrs femoral joint and distal femoral components.

Device

Prothesis, Distal Femur and Femoral Joint
  • Model / Serial
    HMRS Modular Resection System. Catalog Number/Lot Codes: HMRS Distal Femur (Part No: 6367-1-112, 6367-1-114, 6367-1-116, 6367-1-212, 6367-1-214, 6367-1-216. 6467-1-112, 6467-1-114, 6467-1-116, 6467-1-212, 6467-1-214, 6467-1-216 HMRS Femoral Joint (Part No: 6365-0-010, 6365-0-020 and 6465-0-010, 6465-0-020)
  • Product Description
    Prothesis, Knee, hip, Femorotibial, Semi-constrained
  • Manufacturer
    Stryker Howmedica Osteonics Corp

Manufacturer

Stryker Howmedica Osteonics Corp
  • Manufacturer Parent Company (2017)
    Stryker
  • Manufacturers representative
    Zimmo Trading Establishment. Riyadh (01) 4020325
  • Source
    SFDA