French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
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Afssaps has been informed of the implementation of the recall of a batch made by the company Small Bone Innovations. The users concerned have received the attached mail (29/02/2012) (31 KB).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
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In agreement with Afssaps, the company Dade Behring, informed, on February 19, 2009, the users who use the Factor VIII-free Plasma in association with the reagent Pathromtin SL on the BCS / BCS XP systems equipped with the patch 5 , the withdrawal of a lot due to a risk of underestimated results in these configurations. The users of this device in this configuration concerned by this defect, in France, have received the enclosed mail (23/02/2009) (31 KB). The competent European authorities have been notified of this measure by the manufacturer. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
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In agreement with Afssaps, the company Dade Berhing informed, on 28/01/08, the users of the reagent Flex Urea Nitrogen (BUN) for the urea assay on the Dimension system, a withdrawal of batch for lack of performance. The users of this device concerned by this defect, in France, have received the enclosed mail (28/01/2008) (35 KB). The competent European authorities have been informed of this measure by the manufacturer. addressed to laboratory managers, health facility directors and local correspondents for reactive surveillance for dissemination to the concerned biology departments.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
The Afssaps was informed on 05/07/2010 of the implementation of a security action carried out by the company Small Bone Innovations. The users concerned have received the attached mail (08/07/2010) (33 KB).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
The Afssaps was informed on 22/04/2011 of the implementation of a recall made by the company Small Bone Innovations. The users concerned have received the attached mail (06/05/2011) (33 KB).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
The ANSM has been informed of the implementation of the recall of a batch carried out by the company Small Bone Innovations. The users concerned received the attached mail (21/12/2012) (56 KB).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a recall made by the company Small Bone Innovations .. The users concerned have received the attached mail (07/09/2012) (25 KB).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
ANSM has been informed of the implementation of a recall made by Small Bone Innovations. The users concerned received the attached mail (07/10/2013) (170 KB).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
On May 11, 2009, the company SMITH and NEPHEW withdrew from the market lots 20154971 and 20148707 of the reference 7206010 of the medical device called "sterile shaving knives for single use - BONECUTTER full radius 5.5 mm", following a possible defect of sealing at the level of the packaging. The company SMITH and NEPHEW has directly notified the recipients of the incriminated lots with the message attached (13/05/2009) (42 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
On 02/06/09, the company SMITH and NEPHEW removed from the market the batches of the references cited in the attached recall message of the named medical devices (tubings). DYONICS 2. Fluid Management System Disposable Inflow / Outflow Tubeset With Single Suctio. Disposable inlet / outlet manifold for fluid management system (simple suction) DYONICS 2. Fluid Management System Disposable Inflow / Outflow Tubeset With Forked Suctio Disposable inlet / outlet tubing for fluid management system (suction in This recall follows a manufacturing defect of the plastic trays in which these pipes are conditioned.This manufacturing defect can potentially compromise the sterility of these pipes.The company SMITH and NEPHEW directly warned the recipients of the batches in question. the attached message (04/06/2009) (24 ko) validated by Afssaps This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
In agreement with Afssaps, Smith & Nephew, on 28/01/2010, informed users of the PROMOS Standard inclination modules of a product recall. The users concerned, in France, received the attached mail (04/02/2010) (129 KB). The competent European authorities have been informed of this measure by manufacturer. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
In agreement with Afssaps, the company Smith & Nephew Orthopedics, informed, on 11/01/2010, the users of the JOURNEY UNI and JOURNEY DEUCE of a product recall. The users concerned, in France, have received the attached mail (13/01/2010) (86 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
In agreement with Afssaps, the company Smith & Nephew SAS, informed the 06.05.10, users of the endofemoral sighting arm of a withdrawal of lots. The users concerned, in France, have received the attached mail (12/05/2010) (72 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
Afssaps has been informed of the implementation of a recall made by Smith & Nephew. The affected users received the attached mail (18/07/2011) (6288 KB).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
The Agency has been informed of the implementation of a recall of the lids of two lots of sterilization boxes carried out by SMITH & NEPHEW. The affected users have received the attached mail (15/11/2011) (18 KB).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
Afssaps has been informed of the implementation of a recall carried out by SMITH & NEPHEW. The affected users received the attached mail (16/11/2011) (16 KB).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
Afssaps was informed on January 17, 2011 of the implementation of a recall made by Smith & Nephew. The users concerned have received the attached mail (21/01/2011) (21 KB).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
Afssaps was informed on 25/02/2011 of the implementation of a batch recall carried out by the company Smith and Nephew. The users concerned have received the attached mail (07/03/2011) (83 KB).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
The Agency has been informed of the implementation of a recall by Smith & Nephew. The users concerned have received the attached mail (03/05/2012) (19 KB).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
The Agency has been informed of the implementation of a recall by Smith and Nephew. The users concerned have received the attached mail (27/04/2012) (147 KB).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
Smith and Nephew have informed users of Twinfix Ultra Ti preloaded anchors of a recall of multiple batches. The users concerned, in France, received the attached mail (16/07/2012) (39 KB). This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
On May 30, 2008, Smiths Medical France withdrew from the market batches manufactured between October 2007 and February 2008 medical devices called "LogiCal, TranStar, NovaTrans with Trigger flush", manufactured by Smiths Medical International Ltd, following the malfunction of a number of sets, for which the infusion rate is higher than the specified nominal value of 3 ml / h. This excess flow entails a risk of over-perfusion for the patient but also an error in reading the pressure. The company Smiths Medical France directly notified the recipients of the incriminated lots with the message attached (30/05/2008) (40 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a recall made by Smith and Nephew .. The users concerned have received the attached mail (22/08/2012) (62 KB).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
ANSM has been informed of the recall of the ALLEVYN CAVITY hydrocellular dressings (reference 66007326 - lots 1241, 1242, 1243) carried out by Smith & Nephew. The users and distributors concerned received the attached mail (13/02/2013) (121 KB).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
ANSM has been informed of the implementation of a batch recall carried out by Smith & Nephew. The users concerned have received the attached mail (30/04/2013) (85 KB).