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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a lot withdrawal action carried out by TORNIER. The users concerned have received the attached mail (15/01/2018) (563 KB). This safety action is registered with the ANSM under the number R1721582.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a safety action / withdrawal of batch / withdrawal of product made by ABIGO MEDICAL AB. The users concerned have received the attached mail (08/01/2018 ) (90 KB). This safety action is registered at ANSM under the number R1800043.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a withdrawal of product by the company Sybron Endo .. The users concerned have received the attached mail (22/03/2018) (672 KB). This safety action is registered with ANSM under the number R1800085.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a lot withdrawal carried out by the company MENICON CO, Ltd .. The users concerned have received the attached mail (09/01/2018) (293 KB). This safety action is registered at ANSM under the number R1800276.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Drape, surgical - Product Code KKX
Causa
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
Acción
Firm issued field safety notice to all customers on March 16, 2015. Field safety notice includes acknowledgement form to be returned to recalling firm. A second letter was sent on May 12, 2015 to inform users that the date that the drape product unaffected by the issue will not be availalble untisl October/November 2015, not May 2015 as stated in the original communication.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a withdrawal of products made by the company MAQUET .. The users concerned have received the attached mail (20/02/2018) (557 KB). This safety action is registered with the ANSM under the number R1800284
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.
Notas adicionales en la data
Acción
ANSM has been informed of the implementation of a product lot withdrawal carried out by Implant Direct Sybon Manufacturing LLC. The users concerned have received the attached mail (30/01/2018) (234 KB). This safety action is registered with the ANSM under the number R1800415.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a lot withdrawal action carried out by the company EUROS. The users concerned have received the attached letter (17/01/2018) (54 KB). This security action is registered with the ANSM under the number R1800549.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a batch withdrawal carried out by the company CAIR LGL .. The users concerned have received the attached mail (22/01/2018) (242 KB). This safety action is registered at ANSM under the number R1800733.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a product withdrawal action carried out by the company ZIMMER BIOMET .. The users concerned have received the attached mail (19/01/2018) (129 KB). This safety action is registered at ANSM under number R1800845.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Acción
Recall letters were sent on 11/21/2014 to consignees requesting them to discontinue use and quarantine the products. The letter includes a reply form to be returned. The letter to the distributors requested a sub-recall, and included a recall letter to be sent to their accounts.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a withdrawal of lots made by the company Qiagen .. The users concerned have received the attached mail (29/01/2018) (78 KB). This safety action is registered at ANSM under number R1800924.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a lot withdrawal carried out by IBL INTERNATIONAL. The users concerned have received the attached letter (26/01/2018) (330 KB). This safety action is registered at ANSM under number R1800930.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a lot withdrawal made by ALCON. The users concerned have received the attached mail (22/01/2018) (387 KB). This safety action is registered at ANSM under the number R1800952.
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.
Notas adicionales en la data
Acción
ANSM has been informed of the implementation of a lot withdrawal carried out by VascoMed Gmbh. The users concerned have received the attached mail (06/02/2018) (57 KB). This safety action is registered at ANSM under number R1800953.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a product withdrawal action carried out by DEPUY SYNTHES. The users concerned have received the attached letter (29/01/2018) (122 KB). This safety action is registered with the ANSM under the number R1801019.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a lot withdrawal action carried out by SPINEART. The users concerned have received the attached letter (25/01/2018) (402 KB). This safety action is registered at ANSM under the number R1801062.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a lot withdrawal action carried out by the company DePuy. The users concerned received the attached mail (01/02/2018) (170 KB). This safety action is registered at ANSM under the number R1801192.
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.
Notas adicionales en la data
Acción
ANSM has been informed of the implementation of a security / batch withdrawal action carried out by COLOPLAST A / S. The users concerned received the attached mail (30/01/2018) (658 KB). This safety action is registered with the ANSM under the number R1801242.
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.
Notas adicionales en la data
Acción
ANSM has been informed of the implementation of a lot withdrawal by Ortho-Clinical Diagnostics, Inc. (Rochester). The users concerned received the attached mail (30/01/2018) (266 KB). This safety action is registered at ANSM under the number R1801316.
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.
Notas adicionales en la data
Acción
ANSM has been informed of the implementation of a batch withdrawal carried out by Phadia / Thermofisher. The users concerned received the attached mail (01/02/2018) (411 KB). This safety action is registered with the ANSM under the number R1801469.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a batch withdrawal action carried out by ORTHOFIX. The users concerned have received the attached mail (02/02/2018) (144 KB). This safety action is registered at ANSM under the number R1801475.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
General surgery tray (kit) - Product Code LRO
Causa
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Acción
Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a lot withdrawal action carried out by the company FH Industrie .. The users concerned have received the attached letter (01/02/2018) (429 ko). This safety action is registered at ANSM under the number R1801574.
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.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a lot withdrawal carried out by Valtech Cardio Ltd. The users concerned have received the attached mail (13/02/2018) (155 KB). ANSM investigations are ongoing. This safety action is registered at ANSM under the number R1801579.