Events

Field Safety Notices about Affixus Hip Fracture Nail

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by Biomet Orthopaedics.

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
    Field Safety Notice
  • Event ID
    1364
  • Date
    2017-12-01
  • Event Country
    Czechia
  • Event Source
    MHSIDCCCDMIS
  • Event Source URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alerts
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 data from the U.S. and the Czech Republic.
  • Extra notes in the data

Device

Affixus Hip Fracture Nail
  • Model / Serial
    Catalog Number: 814309180 814309260 814309320 814309340 814309360 814309400 814309420 814309440 814309460 814311180 814311300 814311380 814311440 814311460 814313260 814313320 814409260 814409340 814409380 814409440 814411320 814411360 814411440 814509180 814509260 814509300 814509320 814509340 814509360 814509380 814509400 814509420 814509440 814511180 814511260 814511280 814511300 814511320 814511340 814511360 814511380 814511400 814511420 814511440 814513280 814513300 814513440 814513460 814609280 814609300 814609320 814609340 814609400 814609420 814609440 814611260 814611280 814611300 814611340 814611380 814611400 814611420 814611440 814611460 814613460 Batch Number: 398590, 507350, 595480, 788580, 893400, 398610, 512520, 666800, 788620, 893410, 406280, 535120, 669850, 788630, 893430, 437960, 535130, 701480, 788650, 893450, 438020, 535150, 701640, 858640, 893460, 438040, 535230, 701700, 858740, 893470, 459160, 535240, 701720, 858780, 893480, 459170, 535690, 701780, 858790, 893490, 459190, 555180, 701810, 858830, 893500, 459200, 555460, 701830, 858840, 935900, 459230, 555620, 701900, 858900, 935970, 459240, 555730, 701940, 858930, 936020, 459250, 555810, 702050, 858960, 936100, 459270, 581620, 702190, 858970, 936140, 459290, 581630, 702230, 862150, 942010, 480050, 581640, 737630, 862170, 942020, 480070, 581700, 737670, 892880, 942050, 480090, 581910, 760030, 892940, 942070, 480330, 581960, 760270, 892950, 972840, 507130, 581970, 788380, 892960, 972900, 507300, 582240, 788410, 892990, 973000, 507320, 582360, 788440, 893070, 507340, 582380, 788460, 893090,
  • Product Description
    Inactive implantable medical devices
  • Manufacturer
    Biomet Orthopaedics

Manufacturer

Biomet Orthopaedics
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    MHSIDCCCDMIS