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  • Dispositivo 1211
  • Fabricante 31827
  • Evento 5885
  • Implante 4142
Retiro De Equipo (Recall) de BacFix
  • Tipo de evento
    Recall
  • ID del evento
    28488
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0922-04
  • Fecha de inicio del evento
    2002-04-01
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-05-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31987
  • Notas / Alertas
    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
    Appliance, Fixation, Spinal Interlaminal - Product Code KWP
  • Causa
    The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site.
  • Acción
    The firm issued a letter to the consignees on 4/1/2002 requesting distributors to return kits for replacement of the coldwelder.
Retiro De Equipo (Recall) de BacFix
  • Tipo de evento
    Recall
  • ID del evento
    28488
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0921-04
  • Fecha de inicio del evento
    2002-04-01
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-05-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31986
  • Notas / Alertas
    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
    Appliance, Fixation, Spinal Interlaminal - Product Code KWP
  • Causa
    The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site.
  • Acción
    The firm issued a letter to the consignees on 4/1/2002 requesting distributors to return kits for replacement of the coldwelder.
Retiro De Equipo (Recall) de BacFix
  • Tipo de evento
    Recall
  • ID del evento
    28488
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0920-04
  • Fecha de inicio del evento
    2002-04-01
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-05-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31985
  • Notas / Alertas
    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
    Appliance, Fixation, Spinal Interlaminal - Product Code KWP
  • Causa
    The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site.
  • Acción
    The firm issued a letter to the consignees on 4/1/2002 requesting distributors to return kits for replacement of the coldwelder.
Retiro De Equipo (Recall) de Device Recall SCAcuFix Thinline
  • Tipo de evento
    Recall
  • ID del evento
    30399
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0880-05
  • Fecha de inicio del evento
    2002-07-01
  • Fecha de publicación del evento
    2005-06-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-12-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35802
  • Notas / Alertas
    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
    Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
  • Causa
    Complaints were recieved where swivels came out of plate and where the screw went through the plate.
  • Acción
    The firm initiated the recall via telephone communication from sales representatives around August 2002.
Retiro De Equipo (Recall) de TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006....
  • Tipo de evento
    Recall
  • ID del evento
    25007
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0170-04
  • Fecha de inicio del evento
    2002-09-09
  • Fecha de publicación del evento
    2003-11-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-12-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25008
  • Notas / Alertas
    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
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
  • Causa
    Inaccurate dimensions of the device. offshore manufacturer recalled product, some of which have been implanted.
  • Acción
    Certified letters were sent out to the 2 providers that had implanted the device. The remaining inventory was exported back to the manufacturer.
Retiro De Equipo (Recall) de Ascension MCP
  • Tipo de evento
    Recall
  • ID del evento
    25057
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0550-03
  • Fecha de inicio del evento
    2002-10-31
  • Fecha de publicación del evento
    2003-02-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-12-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25089
  • Notas / Alertas
    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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code ---
  • Causa
    Literature approved for international distribution only was distributed domestically.
  • Acción
    The firm began to contact all US distributors on October 31, 2002, and all US sales representatives on November 1, 2002, by e-mail to initiate an examination of all Ascension MCP professional labeling in their stock, and request return of incorrect labeling. The firm additionally, initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request.
Retiro De Equipo (Recall) de Ascension PIP
  • Tipo de evento
    Recall
  • ID del evento
    25056
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0549-03
  • Fecha de inicio del evento
    2002-10-31
  • Fecha de publicación del evento
    2003-02-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-12-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25088
  • Notas / Alertas
    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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code ---
  • Causa
    Brochures approved for international distribution only were distributed domestically.
  • Acción
    The firm began to contact all US distributors on October 31, 2002 and all US sales representatives on November 1, 2002, by e-mail to inititate an examination of all pertinent professional labeling in their stock, and request return of incorrect labeling. The firm initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request.
Retiro De Equipo (Recall) de Device Recall Smith & Nephew ACUFEX RapPac ACL Accessory Kit
  • Tipo de evento
    Recall
  • ID del evento
    25082
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0413-03
  • Fecha de inicio del evento
    2002-11-08
  • Fecha de publicación del evento
    2003-01-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-04-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25125
  • Notas / Alertas
    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
    Arthroscope - Product Code HRX
  • Causa
    Potential for non sterility as package tray does not contain aeration holes for eto processing.
  • Acción
    Smith & Nephew notified customers by letter on 11/8/02. Users are requested to remove stock and return to Smith & Nephew.
Retiro De Equipo (Recall) de Device Recall Citation TMZF HA Hip Stem Right
  • Tipo de evento
    Recall
  • ID del evento
    25085
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0350-03
  • Fecha de inicio del evento
    2002-11-12
  • Fecha de publicación del evento
    2002-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-04-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25131
  • Notas / Alertas
    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
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate - Product Code MEH
  • Causa
    Hip stem fractures in the neck area.
  • Acción
    Letters to Surgeons was sent certified mail on Nov. 4, 2002. Letters to Howmedica agents send on Nov. 12, 2002.
Retiro De Equipo (Recall) de Device Recall Citation TMZF HA Hip Stem Right
  • Tipo de evento
    Recall
  • ID del evento
    25085
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0349-03
  • Fecha de inicio del evento
    2002-11-12
  • Fecha de publicación del evento
    2002-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-04-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25130
  • Notas / Alertas
    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
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate - Product Code MEH
  • Causa
    Hip stem fractures in the neck area.
  • Acción
    Letters to Surgeons was sent certified mail on Nov. 4, 2002. Letters to Howmedica agents send on Nov. 12, 2002.
Retiro De Equipo (Recall) de Device Recall Stryker Howmedica Osteonics
  • Tipo de evento
    Recall
  • ID del evento
    25321
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0467-03
  • Fecha de inicio del evento
    2002-12-02
  • Fecha de publicación del evento
    2003-01-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-08-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25594
  • Notas / Alertas
    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
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate - Product Code MEH
  • Causa
    Product mix-up. 16mm stem in a 18mm package.
  • Acción
    Branches and agents were notified via letter on 12/2/2002. Hospitals were notified on 12/2/2002 via FedEx to OR Supervisors.
Retiro De Equipo (Recall) de Device Recall Fixion Interlocking Proximal Femoral Intramedullary N...
  • Tipo de evento
    Recall
  • ID del evento
    25800
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0943-03
  • Fecha de inicio del evento
    2002-12-11
  • Fecha de publicación del evento
    2003-06-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-04-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26491
  • Notas / Alertas
    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
    Nail, Fixation, Bone, Metallic - Product Code NDH
  • Causa
    The fixion interlocking proximal femoral hip pegs are defective due to possible tension failure.
  • Acción
    The first letter, dated Monday October 14, 2002, went out to 10 of the firm''s agents who directly handled this line of product. The firm then sent out a follow-up letter, dated Wednesday December 11, 2002, to the same agents that they had previously made contact with to assure their knowledge regarding the recall.
Retiro De Equipo (Recall) de Device Recall Hip Prostheses
  • Tipo de evento
    Recall
  • ID del evento
    25395
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0569-03
  • Fecha de inicio del evento
    2002-12-26
  • Fecha de publicación del evento
    2003-02-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-04-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25741
  • Notas / Alertas
    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 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 data.
  • Notas adicionales en la data
  • Causa
    Cleaning agent residue from packaging material was adhering to implantable hip stems.
  • Acción
    Consignees were notified on 12/26/2002 via telephone and e-mail.
Retiro De Equipo (Recall) de Device Recall Hip Prostheses
  • Tipo de evento
    Recall
  • ID del evento
    25395
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0568-03
  • Fecha de inicio del evento
    2002-12-26
  • Fecha de publicación del evento
    2003-02-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-04-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25740
  • Notas / Alertas
    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 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 data.
  • Notas adicionales en la data
  • Causa
    Cleaning agent residue from packaging material was adhering to implantable hip stems.
  • Acción
    Consignees were notified on 12/26/2002 via telephone and e-mail.
Retiro De Equipo (Recall) de Device Recall Hip Prostheses
  • Tipo de evento
    Recall
  • ID del evento
    25395
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0567-03
  • Fecha de inicio del evento
    2002-12-26
  • Fecha de publicación del evento
    2003-02-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-04-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25739
  • Notas / Alertas
    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 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 data.
  • Notas adicionales en la data
  • Causa
    Cleaning agent residue from packaging material was adhering to implantable hip stems.
  • Acción
    Consignees were notified on 12/26/2002 via telephone and e-mail.
Retiro De Equipo (Recall) de Device Recall Hip Prostheses
  • Tipo de evento
    Recall
  • ID del evento
    25395
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0566-03
  • Fecha de inicio del evento
    2002-12-26
  • Fecha de publicación del evento
    2003-02-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-04-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25735
  • Notas / Alertas
    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 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 data.
  • Notas adicionales en la data
  • Causa
    Cleaning agent residue from packaging material was adhering to implantable hip stems.
  • Acción
    Consignees were notified on 12/26/2002 via telephone and e-mail.
Retiro De Equipo (Recall) de Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head wit...
  • Tipo de evento
    Recall
  • ID del evento
    25257
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0461-03
  • Fecha de inicio del evento
    2003-01-06
  • Fecha de publicación del evento
    2003-01-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-12-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25487
  • Notas / Alertas
    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
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
  • Causa
    Compression test results are not in accordance with device approval submission.
  • Acción
    Products distributed to the U.S. market are being recalled via letter to users dated 1/6/2003, which was sent via certified mail. Customers are being asked to return product on hand to Zimmer.
Retiro De Equipo (Recall) de Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head wit...
  • Tipo de evento
    Recall
  • ID del evento
    25257
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0460-03
  • Fecha de inicio del evento
    2003-01-06
  • Fecha de publicación del evento
    2003-01-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-12-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25485
  • Notas / Alertas
    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
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
  • Causa
    Compression test results are not in accordance with device approval submission.
  • Acción
    Products distributed to the U.S. market are being recalled via letter to users dated 1/6/2003, which was sent via certified mail. Customers are being asked to return product on hand to Zimmer.
Retiro De Equipo (Recall) de Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head wit...
  • Tipo de evento
    Recall
  • ID del evento
    25257
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0459-03
  • Fecha de inicio del evento
    2003-01-06
  • Fecha de publicación del evento
    2003-01-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-12-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25484
  • Notas / Alertas
    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
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
  • Causa
    Compression test results are not in accordance with device approval submission.
  • Acción
    Products distributed to the U.S. market are being recalled via letter to users dated 1/6/2003, which was sent via certified mail. Customers are being asked to return product on hand to Zimmer.
Retiro De Equipo (Recall) de Modular Replacement System with Extra-Cortical Porous Coating, Femor...
  • Tipo de evento
    Recall
  • ID del evento
    25460
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0588-03
  • Fecha de inicio del evento
    2003-01-07
  • Fecha de publicación del evento
    2003-02-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-07-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26175
  • Notas / Alertas
    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
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
  • Causa
    Some components have disassociated post-operatively resulting in additional surgery to the patient.
  • Acción
    Notification letters were sent to Howmedica sales agents and Operating Room Supervisors via FedEx on 1/7/2003. On 2/12/2003, Howmedica again sent out notification letters on the extended recalled devices.
Retiro De Equipo (Recall) de Modular femoral and proximal tibial replacement system consisting of...
  • Tipo de evento
    Recall
  • ID del evento
    25460
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0587-03
  • Fecha de inicio del evento
    2003-01-07
  • Fecha de publicación del evento
    2003-02-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-07-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25872
  • Notas / Alertas
    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
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
  • Causa
    Some components have disassociated post-operatively resulting in additional surgery to the patient.
  • Acción
    Notification letters were sent to Howmedica sales agents and Operating Room Supervisors via FedEx on 1/7/2003. On 2/12/2003, Howmedica again sent out notification letters on the extended recalled devices.
Retiro De Equipo (Recall) de Device Recall Versys Hip System femoral stem
  • Tipo de evento
    Recall
  • ID del evento
    25375
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0477-03
  • Fecha de inicio del evento
    2003-01-07
  • Fecha de publicación del evento
    2003-01-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-02-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25703
  • Notas / Alertas
    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
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented - Product Code LPH
  • Causa
    The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
  • Acción
    Recall letters dated 1/7/03 were sent to each U.S. consignee via certified mail, requesting that they contact Zimmer for pick-up of the products if any was in stock. Ex-U.S. consignees were notified via e-mail.
Retiro De Equipo (Recall) de Device Recall Versys Hip System femoral stem
  • Tipo de evento
    Recall
  • ID del evento
    25375
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0476-03
  • Fecha de inicio del evento
    2003-01-07
  • Fecha de publicación del evento
    2003-01-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-02-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25702
  • Notas / Alertas
    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
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented - Product Code LPH
  • Causa
    The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
  • Acción
    Recall letters dated 1/7/03 were sent to each U.S. consignee via certified mail, requesting that they contact Zimmer for pick-up of the products if any was in stock. Ex-U.S. consignees were notified via e-mail.
Retiro De Equipo (Recall) de Device Recall Versys Hip System femoral stem
  • Tipo de evento
    Recall
  • ID del evento
    25375
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0475-03
  • Fecha de inicio del evento
    2003-01-07
  • Fecha de publicación del evento
    2003-01-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-02-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25701
  • Notas / Alertas
    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
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented - Product Code LPH
  • Causa
    The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
  • Acción
    Recall letters dated 1/7/03 were sent to each U.S. consignee via certified mail, requesting that they contact Zimmer for pick-up of the products if any was in stock. Ex-U.S. consignees were notified via e-mail.
Retiro De Equipo (Recall) de Device Recall Versys Hip System femoral stem
  • Tipo de evento
    Recall
  • ID del evento
    25375
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0474-03
  • Fecha de inicio del evento
    2003-01-07
  • Fecha de publicación del evento
    2003-01-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-02-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25700
  • Notas / Alertas
    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
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented - Product Code LPH
  • Causa
    The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
  • Acción
    Recall letters dated 1/7/03 were sent to each U.S. consignee via certified mail, requesting that they contact Zimmer for pick-up of the products if any was in stock. Ex-U.S. consignees were notified via e-mail.
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Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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