The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Removal from the market of certain references and lots of several products manufactured by Biomet 3i, USA, due to a defect in the sealing of the container that could compromise its sterility.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Removal from the market of certain references and lots of the Low Profile dental pillars, manufactured by Biomet 3i, USA, due to a defect in the sealing of the bags that could compromise their sterility.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Withdrawal from the market of batch 2016031461 of the OSSEOTITE® Certain® 4 X 11.5 mm dental implant (IOSS411 code), manufactured by Biomet 3i, USA, due to a packaging error.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Withdrawal from the market of certain references and lots of several products manufactured by Biomet 3i, USA, due to a defect in the sealing of the container that could compromise the sterility of the products.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Recall from the market of certain references of the Provide Protective Covers (PPC) and the Provide Printing Copes (PIC), manufactured by Biomet 3i, USA, as they have been determined to cause a positive cytotoxic response (Grade 4).
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Removal from the market of certain references and lots of dental implants, manufactured by Biomet 3i, USA, due to the possibility that they present, in part or in all its surface, a darker appearance.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Modification of the recommended steam sterilization times with gravity system for certain kits and trays manufactured by Biomet 3i, USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
: Withdrawal from the market of the BellaTek® Zirconia Pillars, EDAZ and EDAZX models, manufactured by Biomet 3i, USA, due to the possible fracture of the abutment.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Removal from the market of certain references and batches of endosseous dental implants, manufactured by Biomet 3i, USA
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Withdrawal from the market of certain batches of OSSEOTITE® endosseous dental implants, manufactured by Biomet 3i, USA
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Withdrawal from the market of certain batches of True OSSEOTITE® 2 Certain® Conical and Full OSSEOTITE® Certain® Parallel Walls, manufactured by Biomet 3i, due to the possibility that the hexagon is not deep enough.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Withdrawal from the market of lot 2011090751 of the product Osseotite® Tapered Certain® Implant, manufactured by Biomet 3i, USA, due to the possibility of not having an internal thread.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Possibility that some packages of the lots 2010100001, 2010080684 and 2010090191 of the product LPCCC1, calcined hexagonal cylinder, manufactured by Biomet 3i, USA, contain the product LPCCC2, rotary cylinder castable.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Removal from the market of certain batches of the Certain 3mm Low Profile dental abutment, ILPAC3217, manufactured by Biomet 3i, United States, because some containers may contain the 5mm abutment, ILPAC5217
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Possibility that the locking system of the internal cannula in the external cannula of the TRACOE twist and TRACOE experc set twist systems, manufactured by TRACOE medical GmbH, between December 2012 and June 2013, is too tight or too tight.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Cessation of the use of batch 1612319 of the "kit anti intrinsic factor alegria", reference ORG 247, and batch 1612153 of the "Kit anti-mycoplasma pneumoniae IGM ABS", reference ORG 915MX, manufactured by ORGENTEC Diagnostika GmbH, Germany, due to a possible defect in the sealing of the container of the strips.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Cessation of the use and recall of lot 1603703 of the Anti-beta-2-glycoprotein I IgG assay kit, manufactured by Orgentec Diagnostika GmbH, Germany, due to the possibility of obtaining high and false positive results.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Cessation of use of certain batches of the product Alegria® Anti-Intrinsic Factor, reference ORG 247, manufactured by Orgentec Diagnostika GmbH, Germany, due to the possibility of obtaining false negative results.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Withdrawal from the batch market 24723031 of the product Alegria® Anti-Intrinsic Factor, reference ORG 247-24, manufactured by Orgentec Diagnostika GmbH, Germany, due to the possibility of obtaining false negatives.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Cessation of the use of batch 21734044 of the r ex-tem® reagent, manufactured by TEM Innovations GmbH, Germany, due to the possibility of obtaining coagulation time values longer than expected.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Inclusion of new warnings in the instructions for use of the ROTEM® sigma complete + hep cartridge, reference 555502, manufactured by TEM Innovations GmbH, Germany.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Removal from the market of certain references and batches of the elastomeric infusion pump "Dosifuser", manufactured by Leventon SAU, Spain, due to the possibility of capillary seizure and infusion being interrupted.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Withdrawal from the market of certain batches of the product "ProTime3® Buckets, Codes PRO3-25 and PRO3-50", manufactured by International Technidyne Corporation, USA, because the results of INR may be lower than expected.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Withdrawal from the market of lots B23198, B23445 and B23605 of HemosIL AcuStar reagent HIT-Ab (PF4-H), manufactured by Instrumentation Laboratory, Co., USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Withdrawal from the market of batch B22585 of the HemosIL AcuStar HIT-Ab reagent (PF4-H), manufactured by Instrumentation Laboratory, Co., USA.