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 DePuySynthes.

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 042 01 16 000
  • Event Initiated Date
    2016-01-12
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8763
  • 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
    Through a complaint investigation, it was discovered that the affected lots of the extraction screw could break or disassemble from the instrument. this may interfere with removal of the pfna and pfna-ii blade from the patient.

Device

Extraction Screw for PFNA Blade
  • Model / Serial
    Part Number : 356.825 Lot Numbers : 2089467; 2090743; 2101443; 2103560; 2107022; 2107094; 2109115; 2114311; 2119302; 2125711; 2127225; 2135962; 2145558; 2155648; 2162089; 2163636; 2168449; 2186602; 2187918; 2193852; 2203709; 2216008; 2225226; 2225992; 2234804; 2238532; 2238533; 2257480; 2257481; 2263698; 2265892; 2311442; 2324437; 2354073; 2357959; 2370086; 2389952; 2401175; 2416428; 2442559; 2443570; 2450764; 2458359; 2475991; 2484015; 2485474; 2498270
  • Product Description
    The Extraction Screw for PFNA Blade is a part of the PFNA and PFNA II Systems.
  • Manufacturer
    DePuySynthes

Manufacturer

DePuySynthes
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Manufacturers representative
    Johnson & Johnson Medical Meddile East
  • Source
    SFDA