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  • Dispositivo 1211
  • Fabricante 31827
  • Evento 5885
  • Implante 4142
Retiro De Equipo O Alerta De Seguridad para LPS Lower Extremity Dovetail Intercalary Component
  • Tipo de evento
    Recall / Safety Alert
  • ID del evento
    31-127(A)-MD/2006-DC (Re-Reg. 02)
  • Fecha
    2013-12-11
  • País del evento
    India
  • Fuente del evento
    CDSCO
  • URL de la fuente del evento
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • Notas / Alertas
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, 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 India.
  • Notas adicionales en la data
  • Causa
    Lps is a limb preservation system. one of its component of the i.E lower extremity dovetail intercalary component has the potential for the fracture of the female component when exposed to certain physiological loads. this recall is only applied or this component and not the whole knee system.
  • Acción
    - Safety Communication to Inform physicians and patients about the risk of catheter entrapment associated with the use of Onyx. - Specific Changes in the Information of Use to include addltional safety information
Retiro De Equipo (Recall) de PROFEMUR NECK VAR / VAL 8DG
  • Tipo de evento
    Recall
  • ID del evento
    1387831
  • Fecha de publicación del evento
    2015-10-09
  • País del evento
    Greece
  • Fuente del evento
    NOM
  • URL de la fuente del evento
    http://www.eof.gr/web/guest/withdrawalsmedical?p_p_id=62_INSTANCE_Eh5C&p_p_lifecycle=0&p_p_state=maximized&p_p_mode=view&_62_INSTANCE_Eh5C_struts_action=%2Fjournal_articles%2Fview&_62_INSTANCE_Eh5C_groupId=12225&_62_INSTANCE_Eh5C_articleId=1387831&_62_INSTANCE_Eh5C_version=1.0
  • Notas / Alertas
    Greek data is current through July 2018. All of the data comes from the National Organization for Medicines, 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 Greece.
  • Notas adicionales en la data
  • Acción
    Recall PROFEMUR NECK VAR / VAL RPG - Good Re-Announcement
Retiro De Equipo (Recall) de PROFEMUR NECK VAR / VAL 8DG
  • Tipo de evento
    Recall
  • ID del evento
    1376075
  • Fecha de publicación del evento
    2015-09-25
  • País del evento
    Greece
  • Fuente del evento
    NOM
  • URL de la fuente del evento
    http://www.eof.gr/web/guest/withdrawalsmedical?p_p_id=62_INSTANCE_Eh5C&p_p_lifecycle=0&p_p_state=maximized&p_p_mode=view&_62_INSTANCE_Eh5C_struts_action=%2Fjournal_articles%2Fview&_62_INSTANCE_Eh5C_groupId=12225&_62_INSTANCE_Eh5C_articleId=1376075&_62_INSTANCE_Eh5C_version=1.0
  • Notas / Alertas
    Greek data is current through July 2018. All of the data comes from the National Organization for Medicines, 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 Greece.
  • Notas adicionales en la data
  • Acción
    Recovery of batches of the medical device "PROFEMUR NECK VAR / VAL 8DG"
Notificaciones De Seguridad De Campo acerca de Universal Cable
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    03082/09
  • Fecha
    2009-09-22
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/10/2009/03082-09_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de PowerPro, PowerProMax and Mpower Handpieces
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    03076/09
  • Fecha
    2009-09-25
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/12/2009/03076-09_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de surgical handpieces PowerPro®, PowerProMax™ and Mp...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    03614/09
  • Fecha
    2009-10-26
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/12/2009/03614-09_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Universal Cables
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    03626/09
  • Fecha
    2009-10-26
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/10/2009/03626-09_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Synex II Modular Vertebral Body Replacement System
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    03552/09
  • Fecha
    2009-10-27
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2009/03552-09_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de femoral neck component
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    05610/15
  • Fecha
    2015-10-19
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2015/05610-15_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de the Oasys Midline Plates
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    02882/13
  • Fecha
    2013-08-29
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2013/02882-13a_Kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de the Oasys Midline Plates
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    02882/13
  • Fecha
    2013-06-21
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2013/02882-13_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Comprehensive Reverse Shoulder Tray
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    11726/16
  • Fecha
    2017-03-09
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2017/11726-16_Kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de ARDIS Inserter worldwide
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    07561/12
  • Fecha
    2012-12-27
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/06/2012/07561-12_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Notas adicionales en la data
Alerta De Seguridad para Standard Offset Cup Impactor
  • Tipo de evento
    Safety alert
  • Fecha
    2014-03-13
  • Fecha de publicación del evento
    2014-03-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140313a.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: greatbatch medical standard offset cup impactor the united states food and drug administration (fda) has issued a medical device safety alert concerning standard offset cup impactor manufactured by greatbatch medical. the affected device was manufactured from january 2004 through january 2013 and distributed from january 2004 through december 2013. the manufacturer has identified through internal sterility assurance level validation testing that a sterility assurance level of 10-6 is not achieved on the standard offset cup impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current instructions for use provided with the device. the manufacturer has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue. greatbatch has developed new sterilization recommendations that meet acceptable sterility assurance levels (aami st79 standard). customers who have the affected product should immediately begin utilizing the new sterilization instructions. for details, please refer to the following fda websites: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1119-2014&w=03122014&lang=eng http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm388928.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm389005.Htm http://www.Fda.Gov/safety/recalls/ucm388883.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 march 2014.
Alerta De Seguridad para LPS (Limb Preservation System) Lower Extremity Dovetail Intercalary Comp...
  • Tipo de evento
    Safety alert
  • Fecha
    2013-07-19
  • Fecha de publicación del evento
    2013-07-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130719a.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: depuy lps (limb preservation system) lower extremity dovetail intercalary component it has come to our attention that the medical device manufacturer, depuy orthopaedics, inc. has initiated a field safety corrective action concerning its lps (limb preservation system) lower extremity dovetail intercalary component. the affected part number is 1987-19-055. according to the manufacturer, the affected product has the potential for fracture of the female component when exposed to certain physiological loads. bench testing simulating loads under normal walking conditions demonstrated that patients over approximately 200 lbs. (90 kg) are at higher risk and that increasing weight may pose increasing risk. however, common activities such as stair ascent and descent and rising from chairs may exert forces higher than those under normal walking conditions. other factors such as the patient’s musculature, activity level, and overall health should also be considered. the possible clinical implications related to this issue, which could only occur if the product should fracture, include: poor mechanics and loss of function pain dislocation: the separation of the male component from the female component adverse tissue reaction if the broken piece of the female component were to completely break free and cause irritation to the surrounding tissue. damage to bone in areas that are important for revision surgery. surgeon may be unable to conduct revision surgery due to lack of sufficient bone stock, potentially resulting in amputation if no other therapeutic options remain available. the clinical implications above may lead to revision surgery. depuy provides the following advice to the affected customers: customers are advised to stop further distribution or use of the affected products immediately for use in primary surgery. depuy is not recommending prophylactic revision in the absence of symptoms. however, surgeons are encouraged to communicate with patients who received these implants as deemed appropriate (considering weight and activity level). depuy recommends that surgeons review each patient’s case to determine the best treatment options, considering the patient’s weight, activity level and/or any other potential contributing factors. if a patient presents with a fractured lps lower extremity dovetail intercalary component with well‐fixed proximal and distal stems and the surgeon determines that the lps lower extremity dovetail intercalary component is the best treatment option, the company will make the lps lower extremity dovetail intercalary component available. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 july 2013.
Alerta De Seguridad para m/l taper with kinectiv technology femoral stems and necks
  • Tipo de evento
    Safety alert
  • Fecha
    2015-06-23
  • Fecha de publicación del evento
    2015-06-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150623.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: zimmer m/l taper with kinectiv technology femoral stems and necks the united states food and drug administration (fda) has issued medical device safety alerts concerning m/l taper with kinectiv technology femoral stems and necks, manufactured by zimmer. the manufacturer has initiated a voluntary recall of 64 lots (752 implants total) of m/l taper with kinectiv femoral stems and modular necks due to higher than allowed cytotoxicity levels found with the product. the manufacturer found a process monitoring failure that led to higher than expected amounts of manufacturing residues left on the devices. these residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. use of these products may require the need for a revision surgery to replace the affected implant. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda websites: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1699-2015&w=06172015&lang=eng http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm452012.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm451936.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 june 2015.
Notificaciones De Seguridad De Campo acerca de Standard Offset Cup Impactor
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1026
  • Fecha
    2017-03-20
  • País del evento
    Czechia
  • Fuente del evento
    MHSIDCCCDMIS
  • URL de la fuente del evento
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notas / Alertas
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 data from the U.S. and the Czech Republic.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Ardis Interbody System Inserter
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    444:2012/94440
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2013/Instrument-flergangs--Ardis-Interbody-System-Inserter--Zimmer-Inc/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    1649384-11/12/2012-003R
  • Acción
    Products recalled.
Retiro De Equipo (Recall) de Regenerex Ringloc Acetabular Cup
  • Tipo de evento
    Recall
  • ID del evento
    58663
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2458-2011
  • Fecha de inicio del evento
    2011-04-14
  • Fecha de publicación del evento
    2011-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100092
  • 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, uncemented acetabular component) - Product Code LPH
  • Causa
    The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
  • Acción
    Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Immediately locate and remove the affected product. Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product. Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756. For any questions regarding this recall call 574-371-3755 or 574-371-3756.
Retiro De Equipo (Recall) de Regenerex Ringloc Acetabular Cup
  • Tipo de evento
    Recall
  • ID del evento
    58663
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2459-2011
  • Fecha de inicio del evento
    2011-04-14
  • Fecha de publicación del evento
    2011-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100093
  • 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, uncemented acetabular component) - Product Code LPH
  • Causa
    The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
  • Acción
    Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Immediately locate and remove the affected product. Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product. Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756. For any questions regarding this recall call 574-371-3755 or 574-371-3756.
Retiro De Equipo (Recall) de Regenerex Ringloc Acetabular Cup
  • Tipo de evento
    Recall
  • ID del evento
    58663
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2460-2011
  • Fecha de inicio del evento
    2011-04-14
  • Fecha de publicación del evento
    2011-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100095
  • 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, uncemented acetabular component) - Product Code LPH
  • Causa
    The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
  • Acción
    Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Immediately locate and remove the affected product. Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product. Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756. For any questions regarding this recall call 574-371-3755 or 574-371-3756.
Retiro De Equipo (Recall) de Regenerex Ringloc Acetabular Cup
  • Tipo de evento
    Recall
  • ID del evento
    58663
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2461-2011
  • Fecha de inicio del evento
    2011-04-14
  • Fecha de publicación del evento
    2011-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100096
  • 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, uncemented acetabular component) - Product Code LPH
  • Causa
    The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
  • Acción
    Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Immediately locate and remove the affected product. Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product. Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756. For any questions regarding this recall call 574-371-3755 or 574-371-3756.
Retiro De Equipo (Recall) de Regenerex Ringloc Acetabular Cup
  • Tipo de evento
    Recall
  • ID del evento
    58663
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2462-2011
  • Fecha de inicio del evento
    2011-04-14
  • Fecha de publicación del evento
    2011-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100097
  • 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, uncemented acetabular component) - Product Code LPH
  • Causa
    The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
  • Acción
    Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Immediately locate and remove the affected product. Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product. Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756. For any questions regarding this recall call 574-371-3755 or 574-371-3756.
Retiro De Equipo (Recall) de Regenerex Ringloc Acetabular Cup
  • Tipo de evento
    Recall
  • ID del evento
    58663
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2463-2011
  • Fecha de inicio del evento
    2011-04-14
  • Fecha de publicación del evento
    2011-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100098
  • 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, uncemented acetabular component) - Product Code LPH
  • Causa
    The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
  • Acción
    Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Immediately locate and remove the affected product. Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product. Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756. For any questions regarding this recall call 574-371-3755 or 574-371-3756.
Retiro De Equipo (Recall) de Regenerex Ringloc Acetabular Cup
  • Tipo de evento
    Recall
  • ID del evento
    58663
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2464-2011
  • Fecha de inicio del evento
    2011-04-14
  • Fecha de publicación del evento
    2011-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100099
  • 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, uncemented acetabular component) - Product Code LPH
  • Causa
    The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. if the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
  • Acción
    Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Immediately locate and remove the affected product. Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product. Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756. For any questions regarding this recall call 574-371-3755 or 574-371-3756.
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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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