Device Recalls

  • 0 ::
      • Event_date_terminated : 2017-03-24
        • Firm_fei_number : 3006460162
          • Openfda ::
              • Regulation_number : 888.3040
                • Fei_number ::
                    • 0 : 3006460162
                  • Device_name : Screw, Fixation, Bone
                    • Device_class : 2
                      • Medical_specialty_description : Orthopedic
                        • Registration_number ::
                            • 0 : 3006460162
                      • Res_event_number : 74928
                        • Other_submission_description :
                          • K_numbers ::
                              • 0 : K083286
                            • Product_res_number : Z-2843-2016
                              • Product_code : HWC
                                • Root_cause_description : Labeling Mixups/Errors
                                  • Pma_numbers ::

    Device Recalls

    • 1 ::
        • Event_date_terminated : 2017-03-03
          • Firm_fei_number : 3008853977
            • Openfda ::
                • Regulation_number : 882.5950
                  • Fei_number ::
                      • 0 : 3008853977
                    • Device_name : Device, Neurovascular Embolization
                      • K_number ::
                          • 0 : K113412
                            • 1 : K153658
                          • Device_class : 2
                            • Medical_specialty_description : Neurology
                              • Registration_number ::
                                  • 0 : 3008853977
                            • Res_event_number : 74425
                              • Other_submission_description :
                                • K_numbers ::
                                    • 0 : K113412
                                      • 1 : K153658
                                    • Product_res_number : Z-2174-2016
                                      • Product_code : HCG
                                        • Root_cause_description : Process Change Control
                                          • Pma_numbers ::

      Device Recalls

      • 2 ::
          • Event_date_terminated : 2016-12-14
            • Firm_fei_number : 1044713
              • Openfda ::
                  • Regulation_number : 866.3235
                    • Fei_number ::
                        • 0 : 1044713
                      • Device_name : Antiserum, Cf, Epstein-Barr Virus
                        • K_number ::
                            • 0 : K981831
                          • Device_class : 1
                            • Medical_specialty_description : Microbiology
                              • Registration_number ::
                                  • 0 : 1044713
                            • Res_event_number : 73694
                              • Other_submission_description :
                                • K_numbers ::
                                    • 0 : K981831
                                  • Product_res_number : Z-1687-2016
                                    • Product_code : GNP
                                      • Root_cause_description : Unknown/Undetermined by the Firm
                                        • Pma_numbers ::

        Device Recalls

        • 3 ::
            • Event_date_terminated : 2011-12-27
              • Firm_fei_number : 2182269
                • Openfda ::
                    • Regulation_number : 870.1340
                      • Medical_specialty_description : Cardiovascular
                        • Device_name : Introducer, Catheter
                          • Device_class : 2
                        • Res_event_number : 56222
                          • Other_submission_description :
                            • K_numbers ::
                                • 0 : K091137
                                  • 1 : K092575
                                    • 2 : K093130
                                  • Product_res_number : Z-2179-2010
                                    • Product_code : DYB
                                      • Root_cause_description : Process Design
                                        • Pma_numbers ::

          Device Recalls

          • 4 ::
              • Event_date_terminated : 2017-11-21
                • Firm_fei_number : 3006369484
                  • Openfda ::
                      • Regulation_number : 892.1000
                        • Fei_number ::
                            • 0 : 3006369484
                          • Device_name : Coil, Magnetic Resonance, Specialty
                            • K_number ::
                                • 0 : K141832
                              • Device_class : 2
                                • Medical_specialty_description : Radiology
                                  • Registration_number ::
                                      • 0 : 3006369484
                                • Res_event_number : 74477
                                  • Other_submission_description :
                                    • K_numbers ::
                                        • 0 : K141832
                                      • Product_res_number : Z-2312-2016
                                        • Product_code : MOS
                                          • Root_cause_description : Nonconforming Material/Component
                                            • Pma_numbers ::