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.
Notes supplémentaires dans les données
Action
Afssaps has been informed of the implementation of a recall made by Biomet. The affected users have received the attached mail. (23/02/2012) (142 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.
Notes supplémentaires dans les données
Action
ANSM has been informed of the implementation of a recall made by Biomet. The only user concerned has received the attached mail (18/12/2012) (87 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.
Notes supplémentaires dans les données
Action
The ANSM has been informed of the implementation of the recall of a batch carried out by Biomet. The only user concerned received the attached mail (26/11/2012) (91 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.
Notes supplémentaires dans les données
Action
Biomet informed the users of Biomet Bone Cement V cement of a batch recall. The users concerned, in France, received the attached mail (23/07/2012) (24 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.
Notes supplémentaires dans les données
Action
Afssaps has been informed of the implementation of a recall made by Biomet. The users concerned received the attached mail (13/02/2012) (64 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.
Notes supplémentaires dans les données
Action
Afssaps has been informed of the implementation of a recall made by Biomet. The affected users have received the attached mail. (10/02/2012) (66 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.
Notes supplémentaires dans les données
Action
The Afssaps was informed on 10/02/2011 of the implementation of a recall made by Zimmer. The users concerned have received the attached mail (04/03/2011) (90 KB). This recall was triggered by security information released by the manufacturer in May 201..
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.
Notes supplémentaires dans les données
Action
Afssaps has been informed of the implementation of a product recall carried out by Zimmer Spine. The affected users have received the attached mail (10/03/2011) (37 KB). Only one establishment is concerned in France by this product recall.
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.
Notes supplémentaires dans les données
Action
Afssaps was informed on 28/03/2011 of the implementation of a recall made by Zimmer France. Both users concerned received the attached mail (04/04/2011) (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.
Notes supplémentaires dans les données
Action
Afssaps has been informed of the implementation of a recall made by the company Zimmer .. The users concerned have received the attached mail (06/07/2011) (304 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.
Notes supplémentaires dans les données
Action
Afssaps has been informed of the implementation of a batch recall carried out by BIOMET France. The users concerned have received the attached mail (04/08/2011) (127 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.
Notes supplémentaires dans les données
Action
On 18/03/2011, the company BIOMET France has withdrawn from the market the batches of medical devices intended for the knee and hip prosthesis listed in the attached letter (21/03/2011) (100 ko), at the following the detection of a failure to seal the secondary packaging of these implants, which could call into question the sterile barrier of the blister and the sterility at the outer surface of the inner packaging of the implants. The company BIOMET France has directly notified the recipients of the incriminated lots by means of the enclosed message validated by the Afssaps (21/03/2011) (100 KB). This information is intended for directors and correspondents of materiovigilance for dissemination where appropriate 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.
Notes supplémentaires dans les données
Action
Afssaps has been informed of the implementation of the recall of a batch made by Biomet. The affected users have received the attached mail (12/12/2011) (67 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.
Notes supplémentaires dans les données
Action
Afssaps was informed on 23/09/10 of the implementation of a recall made by Zimmer. The users concerned have received the attached mail (30/09/2010) (237 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.
Notes supplémentaires dans les données
Action
The Afssaps has been informed (14/05/2010) (65 ko) by the company ZIMMER, the 29/03/2010, of the recall of lots of skirt heads in stainless steel. In agreement with the Afssaps, the company ZIMMER informed, on 11/05/2010, the users of the Skirt Heads Inox of the additional information following the recall of batches of these dipositifs. The users concerned in France have received the attached letter (14/05/2010) (52 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.
Notes supplémentaires dans les données
Action
In agreement with Afssaps, the company ZIMMER, on 30/04/2010, informed the users of the product removal of the impaction adapter for acetabular implant Continuum. The users concerned in France have received the attached letter (04/05/2010) (54 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.
Notes supplémentaires dans les données
Action
The recall mail from the company Biomet published on 03/09/2010 on the Afssaps website has been modified following an error concerning the reference. The attached mail replaces (14/09/2010) (41 KB) and cancels the previous one (03/09/2010) (51 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.
Notes supplémentaires dans les données
Action
Afssaps was informed on 26/08/2010 of the implementation of a recall made by Biomet France SARL. The users concerned have received the attached mail .. The previous mail with an error, it was replaced on 14/09/2010 by the attached mail (14/09/2010) (41 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.
Notes supplémentaires dans les données
Action
Afssaps was informed on 23/12/10 of the implementation of a batch recall carried out by Biomet France. The users concerned have received the attached mail (31/12/2010) (107 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.
Notes supplémentaires dans les données
Action
Afssaps was informed on 04/10/2010 of the implementation of a recall made by Biomet France SARL. The users concerned have received the attached mail (13/10/2010) (84 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.
Notes supplémentaires dans les données
Action
Afssaps was informed on 23/09/10 of the implementation of a product recall carried out by Biomet. The users concerned have received the attached mail (05/10/2010) (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.
Notes supplémentaires dans les données
Action
The Afssaps was informed on 07/06/2010 of a withdrawal of a lot of femoral stems EXCEPTION® made by the company BIOMET. The users concerned, in France, have received the attached mail (10/06/2010) (20 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.
Notes supplémentaires dans les données
Action
On July 2, 2009, the company BIOMET France withdrew from the market batches between 0000404732 and 0000432063 of the medical device called "rasps 2U", references A3800L01 to 3 - A3800R01 to 3, the usual performances including the mechanical resistance not being guaranteed . The company BIOMET has directly notified the recipients of the incriminated lots with the message attached (06/07/2009) (36 KB) validated by the 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 will be 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.
Notes supplémentaires dans les données
Action
The Afssaps was informed on 07/04/2008 of a recall of the UP tION stem centerers carried out by Biomet on 15/04/2008 following 3 ruptures of these centralizers consecutive to extreme uses. The users concerned, in France, received the attached mail (21/04/2008) (16 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.
Notes supplémentaires dans les données
Action
On 11/04/08, the company ZIMMER makes a second batch recall of the references cited in the annex (11/04/2008) (12 ko) of the attached recall message, of the medical device called HEMOVAC autotransfusion system. and HEMOVAC kits following possible microperforations at the packaging level that could affect the sterility integrity of these systems. The lots to consider are different from the first rappe. . The company ZIMMER has directly notified the recipients of the incriminated lots with the message attached (11/04/2008) (24 KB) validated by Afssaps. This information is addressed to directors and correspondents of materiovigilance for dissemination, where appropriate, to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.