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  • Device 2843
  • Manufacturer 2843
  • Event 2877
  • Implant 0
Field Safety Notices about Zimmer Trabecular Metal™ Reverse Shoulder Instrumentation Liner Impactor
  • Type of Event
    Field Safety Notice
  • Event Number
    LMST-2012073244
  • Date
    2012-07-20
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2012/zimmer-trabecular-metal-reverse-shoulder-instrumentation-liner-impactor/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about nexgen monoblock tibial provisional / borer
  • Type of Event
    Field Safety Notice
  • Event Number
    2015014944
  • Date
    2015-01-31
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2015/01/nexgen-monoblock-tibial-provisoriskborfoerer/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about Ardis Inserter
  • Type of Event
    Field Safety Notice
  • Event Number
    LMST-2012121422
  • Date
    2012-12-21
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2012/ardis-inserter-21-december-2012/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about trilogy bone screws
  • Type of Event
    Field Safety Notice
  • Event Number
    2014123552
  • Date
    2014-12-23
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2014/trilogy-knogleskruer/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about REVITAN prox. spout and REVITAN prox. cylindrical
  • Type of Event
    Field Safety Notice
  • Event Number
    2016033047
  • Date
    2016-03-18
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/03/revitan-prox-spout-and-revitan-prox-cylindrical/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about Biolox Delta Head, Durasul
  • Type of Event
    Field Safety Notice
  • Event Number
    2015012307
  • Date
    2015-01-17
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2015/01/biolox-delta-head,-durasul/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about Metasul Femoral Head 40 S / -3,5 Taper 12/14
  • Type of Event
    Field Safety Notice
  • Event Number
    2016014133
  • Date
    2016-02-02
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/02/metasul-femoral-head-40-s-35-taper-1214/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about patient labels for zimmer products made before 2010
  • Type of Event
    Field Safety Notice
  • Event Number
    LMST-2012080719
  • Date
    2012-08-23
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2012/patientmaerkater-for-zimmer-produkter-fremstillet-foer-2010/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about Normed Charcot Osteotome Chisel
  • Type of Event
    Field Safety Notice
  • Event Number
    2018032935
  • Date
    2018-03-19
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2018/03/normed-charcot-osteotome-chisel/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about Werber Countersink Cannulated for micro CBS screws
  • Type of Event
    Field Safety Notice
  • Event Number
    2017062222
  • Date
    2017-06-16
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2017/06/werber-countersink-cannulated-for-micro-cbs-screws/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about Modular femoral heads
  • Type of Event
    Field Safety Notice
  • Event Number
    2017023682
  • Date
    2017-02-27
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2017/02/modular-femoral-heads/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about Specific Hip and Trauma instruments
  • Type of Event
    Field Safety Notice
  • Event Number
    2017100916
  • Date
    2017-10-05
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2017/10/specific-hip-and-trauma-instruments/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about Nexgen TM Tibial Impactor Pad
  • Type of Event
    Field Safety Notice
  • Event Number
    2014111414
  • Date
    2014-11-11
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2014/nexgen-tm-tibial-impactor-pad/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about vitality® shear-off set screw
  • Type of Event
    Field Safety Notice
  • Event Number
    2018083591
  • Date
    2018-08-28
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2018/08/vitality-shear-off-saetskrue/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about Twist drill
  • Type of Event
    Field Safety Notice
  • Event Number
    2016064394
  • Date
    2016-06-29
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/06/twist-drill/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about various polyethylene implants
  • Type of Event
    Field Safety Notice
  • Event Number
    2017034003
  • Date
    2017-03-27
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2017/03/diverse-polyethylenimplantater/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about Echo® Bi-Metric® Hip Stem Digital Templates
  • Type of Event
    Field Safety Notice
  • Event Number
    2017032917
  • Date
    2017-03-20
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2017/03/echo-bi-metric-hip-stem-digital-templates/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about trauma guidewires
  • Type of Event
    Field Safety Notice
  • Event Number
    2018071501
  • Date
    2018-07-11
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2018/07/traumeguidewirer/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about Revitan® Revision Stem System
  • Type of Event
    Field Safety Notice
  • Event Number
    2017012600
  • Date
    2017-01-18
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2017/01/revitan-revision-stem-system/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about NexGen Cruciate Retaining (CR) Micro Articular Surface Components
  • Type of Event
    Field Safety Notice
  • Event Number
    LMST-2012033448
  • Date
    2012-08-23
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2012/nexgen-cruciate-retaining-cr-micro-articular-surface-components/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about trilogy-acetabulum system cup without holes
  • Type of Event
    Field Safety Notice
  • Event Number
    LMST-2012100821
  • Date
    2012-10-05
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2012/trilogy-acetabulumsystemcup-uden-huller/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about Mobile X-ray C-Arms Ziehm Imaging
  • Type of Event
    Field Safety Notice
  • Event Number
    2013050115
  • Date
    2013-05-02
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2013/mobile-x-ray-c-arms-ziehm-imaging/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about Ziehm Vision & Ziehm Solo
  • Type of Event
    Field Safety Notice
  • Event Number
    2016060607
  • Date
    2016-06-05
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/06/ziehm-vision-ziehm-solo/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about InfuseIT
  • Type of Event
    Field Safety Notice
  • Event Number
    2015036582
  • Date
    2015-03-30
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2015/03/infuseit/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
Field Safety Notices about Dental unit XO 4
  • Type of Event
    Field Safety Notice
  • Event Number
    2018013348
  • Date
    2018-01-31
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2018/01/dental-unit-xo-4/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 Denmark.
  • Extra notes in the data
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About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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