Device Recalls

  • 0 ::
      • Event_date_terminated : 2016-10-25
        • Firm_fei_number : 2025851
          • Openfda ::
              • Regulation_number : 876.5980
                • Fei_number ::
                    • 0 : 2025851
                  • Device_name : Gastrointestinal Tubes With Enteral Specific Connectors
                    • K_number ::
                        • 0 : K142297
                      • Device_class : 2
                        • Medical_specialty_description : Gastroenterology, Urology
                          • Registration_number ::
                              • 0 : 2025851
                        • Res_event_number : 73024
                          • Other_submission_description :
                            • K_numbers ::
                                • 0 : K142297
                              • Product_res_number : Z-0934-2016
                                • Product_code : PIF
                                  • Root_cause_description : Device Design
                                    • Pma_numbers ::

    Device Recalls

    • 1 ::
        • Event_date_terminated : 2017-04-13
          • Firm_fei_number : 1000132037
            • Openfda ::
                • Regulation_number : 888.3358
                  • Medical_specialty_description : Orthopedic
                    • Device_name : Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
                      • Device_class : 2
                    • Res_event_number : 72900
                      • Other_submission_description :
                        • K_numbers ::
                            • 0 : K953490
                          • Product_res_number : Z-1160-2016
                            • Product_code : LPH
                              • Root_cause_description : Packaging
                                • Pma_numbers ::

      Device Recalls

      • 2 ::
          • 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

        • 3 ::
            • 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

          • 4 ::
              • 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 ::