• Acerca de la base de datos
  • ¿Cómo usar la IMDD?
  • Descargar la data
  • Preguntas frecuentes
  • Créditos
Vista de la lista Vista de las tarjetas
  • Dispositivo 1211
  • Fabricante 31827
  • Evento 5885
  • Implante 4142
Retiro De Equipo (Recall) de ANCHORLOK
  • Tipo de evento
    Recall
  • ID del evento
    59998
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0063-2012
  • Fecha de inicio del evento
    2011-09-20
  • Fecha de publicación del evento
    2011-10-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104208
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Causa
    The product is labeled with an expiration date without adequate justification.
  • Acción
    The firm, Wright Medical Technology, Inc., sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated September 20, 2011 to all affected consignees. The letters identified the products, the problem, and the actions to be taken. The letter instructed consignees to identify affected inventory. If recalled products are located consignees are instructed to contact customer service at 1-800-238-7117, for specific instructions on how to return the recalled products. The letter asked that this communication be forward to any associated sites if the recalled products were further distributed. Consignees are to complete and return the enclosed notification form by fax to 901-867-7401 or by email to: cathy.park@wmt.com. For questions regarding this recall contact 901-867-4324.
Retiro De Equipo (Recall) de ANCHORLOK
  • Tipo de evento
    Recall
  • ID del evento
    59998
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0064-2012
  • Fecha de inicio del evento
    2011-09-20
  • Fecha de publicación del evento
    2011-10-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104209
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Causa
    The product is labeled with an expiration date without adequate justification.
  • Acción
    The firm, Wright Medical Technology, Inc., sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated September 20, 2011 to all affected consignees. The letters identified the products, the problem, and the actions to be taken. The letter instructed consignees to identify affected inventory. If recalled products are located consignees are instructed to contact customer service at 1-800-238-7117, for specific instructions on how to return the recalled products. The letter asked that this communication be forward to any associated sites if the recalled products were further distributed. Consignees are to complete and return the enclosed notification form by fax to 901-867-7401 or by email to: cathy.park@wmt.com. For questions regarding this recall contact 901-867-4324.
Retiro De Equipo (Recall) de ANCHORLOK
  • Tipo de evento
    Recall
  • ID del evento
    59998
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0065-2012
  • Fecha de inicio del evento
    2011-09-20
  • Fecha de publicación del evento
    2011-10-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104210
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Causa
    The product is labeled with an expiration date without adequate justification.
  • Acción
    The firm, Wright Medical Technology, Inc., sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated September 20, 2011 to all affected consignees. The letters identified the products, the problem, and the actions to be taken. The letter instructed consignees to identify affected inventory. If recalled products are located consignees are instructed to contact customer service at 1-800-238-7117, for specific instructions on how to return the recalled products. The letter asked that this communication be forward to any associated sites if the recalled products were further distributed. Consignees are to complete and return the enclosed notification form by fax to 901-867-7401 or by email to: cathy.park@wmt.com. For questions regarding this recall contact 901-867-4324.
Retiro De Equipo (Recall) de ANCHORLOK
  • Tipo de evento
    Recall
  • ID del evento
    59998
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0066-2012
  • Fecha de inicio del evento
    2011-09-20
  • Fecha de publicación del evento
    2011-10-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104211
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Causa
    The product is labeled with an expiration date without adequate justification.
  • Acción
    The firm, Wright Medical Technology, Inc., sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated September 20, 2011 to all affected consignees. The letters identified the products, the problem, and the actions to be taken. The letter instructed consignees to identify affected inventory. If recalled products are located consignees are instructed to contact customer service at 1-800-238-7117, for specific instructions on how to return the recalled products. The letter asked that this communication be forward to any associated sites if the recalled products were further distributed. Consignees are to complete and return the enclosed notification form by fax to 901-867-7401 or by email to: cathy.park@wmt.com. For questions regarding this recall contact 901-867-4324.
Retiro De Equipo (Recall) de ANCHORLOK
  • Tipo de evento
    Recall
  • ID del evento
    59998
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0067-2012
  • Fecha de inicio del evento
    2011-09-20
  • Fecha de publicación del evento
    2011-10-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104212
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Causa
    The product is labeled with an expiration date without adequate justification.
  • Acción
    The firm, Wright Medical Technology, Inc., sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated September 20, 2011 to all affected consignees. The letters identified the products, the problem, and the actions to be taken. The letter instructed consignees to identify affected inventory. If recalled products are located consignees are instructed to contact customer service at 1-800-238-7117, for specific instructions on how to return the recalled products. The letter asked that this communication be forward to any associated sites if the recalled products were further distributed. Consignees are to complete and return the enclosed notification form by fax to 901-867-7401 or by email to: cathy.park@wmt.com. For questions regarding this recall contact 901-867-4324.
Retiro De Equipo (Recall) de Synthes Spine TPAL Spacer System.
  • Tipo de evento
    Recall
  • ID del evento
    60003
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0161-2012
  • Fecha de inicio del evento
    2011-09-23
  • Fecha de publicación del evento
    2011-11-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104221
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Causa
    Labeling correction for medical device - previous labeling and promotional materials associated with the t-pal spacer system reference the use of t-pal spacer with allograft material. t-pal spacer is currently indicated for use with autograft material. all accounts with record of receiving t-pal implant will receive notification of the labeling correction and a copy of the updated brochure. all.
  • Acción
    SYNTHES sent an URGENT MEDICAL DEVICE LABELING CORRECTION letter dated September 23, 2011, to all affected customers. The labeling has been revised. Updated information packets have been sent to all accounts which included the final labeling and communications to accounts and sales force. Customers were instructed to review the updated supplemental labeling provided in the package Customers were instructed to attach the supplementary technique page to an T-PAL Spacer Brochure that may be in their facility. They can access an electronic version of the Brochure by accesssng Product Literature at the following link: http://us.synthes.com. The new version can be identified by code J10120 located at the bottom right corner of the back cover. To confirm receipt and understanding of the information, customers were requested to complete the Verification Section of the letter and return it to Synthes by either of the following methods: Mail provided postage paid envelope Fax 610-251-9005 Scan/e-mail to FieldAction@synthes.com For any questions call 1-800-420-7025 x5403 or contact their Synthes Spine Sales Consultant.
Retiro De Equipo (Recall) de Synthes Spine ZeroP Instruments and Implants
  • Tipo de evento
    Recall
  • ID del evento
    60004
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0104-2012
  • Fecha de inicio del evento
    2011-09-23
  • Fecha de publicación del evento
    2011-10-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104222
  • 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
    Intervertebral fusion device with bone graft, cervical - Product Code ODP
  • Causa
    Labeling correction - following review of labeling and promotional materials associated with the zero-p implant system, it was found that the materials reference a study where peek-cr is utilized as a cervical interbody spacer. peek-cr is not currently indicated for use as a cervical interbody spacer.
  • Acción
    Synthes (USA) sent an "URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated September 23, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to review the updated supplemental labeling page included with the letter and replace/attach the technique guide page in any Zero-P technique guide that customers may have. The Verification Section of the letter is to be completed and returned to Synthes via fax at 610-251-9005. For questions regarding this notice call 1-800-620-7025 ext. 5403.
Retiro De Equipo (Recall) de Panalock Loop w/ Orthocord
  • Tipo de evento
    Recall
  • ID del evento
    60287
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0318-2012
  • Fecha de inicio del evento
    2011-10-31
  • Fecha de publicación del evento
    2011-11-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104954
  • 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
    Fastener, fixation, biodegradable, soft tissue - Product Code MAI
  • Causa
    Incorrect suture configuration.
  • Acción
    The firm, DePuy Mitek Inc., sent an "URGENT VOLUNTARY PRODUCT RECALL"letter dated October 31, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to not use or sell any of the identified problem products included in this recall; complete the enclosed business reply form and fax to: 1-508-828-3750 or email to: mitekcomplaints@its.jnj.com (note: It is important that we receive this business reply form, even if you have no product remaining in your inventory from the affected lots); isolate all inventory and call 1-877-379-4871 for return goods authorization and replacement product; and return all identified affected product to: (USA)- DePuy Mitek, ATTN: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324 or (foreign)-GMED Healthcare EDC Quality Dept Rue de Luxembourg 5, ZI Trazegnies, BE-6180 Courcelles, Belgium. If you have any questions or concerns with regard to this program, please contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-877-379-4871.
Retiro De Equipo (Recall) de Beuchal Pappas Mobile Bearing Knee System
  • Tipo de evento
    Recall
  • ID del evento
    60138
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0431-2012
  • Fecha de inicio del evento
    2011-09-21
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104501
  • 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
    Prothesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing - Product Code NRA
  • Causa
    On 09/21/2011 endotec, orlando, fl initiated a recall for the beuchel-pappas mobile bearing knee system (bp knee). the bp mobile bearing knee system consists of unapproved mobile (rotating) bearing tibial and patellar components.
  • Acción
    Endotec sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 21, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to examine and quarantine product subject to the recall. Additionally, a Response Form was included with the letter for customers to complete and return to the firm. Call 862-703-6730 for questions regarding this recall.
Retiro De Equipo (Recall) de Beuchal Pappas Mobile Bearing Knee System
  • Tipo de evento
    Recall
  • ID del evento
    60138
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0432-2012
  • Fecha de inicio del evento
    2011-09-21
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104502
  • 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
    Prothesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing - Product Code NRA
  • Causa
    On 09/21/2011 endotec, orlando, fl initiated a recall for the beuchel-pappas mobile bearing knee system (bp knee). the bp mobile bearing knee system consists of unapproved mobile (rotating) bearing tibial and patellar components.
  • Acción
    Endotec sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 21, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to examine and quarantine product subject to the recall. Additionally, a Response Form was included with the letter for customers to complete and return to the firm. Call 862-703-6730 for questions regarding this recall.
Retiro De Equipo (Recall) de Beuchal Pappas Mobile Bearing Knee System
  • Tipo de evento
    Recall
  • ID del evento
    60138
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0433-2012
  • Fecha de inicio del evento
    2011-09-21
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104503
  • 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
    Prothesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing - Product Code NRA
  • Causa
    On 09/21/2011 endotec, orlando, fl initiated a recall for the beuchel-pappas mobile bearing knee system (bp knee). the bp mobile bearing knee system consists of unapproved mobile (rotating) bearing tibial and patellar components.
  • Acción
    Endotec sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 21, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to examine and quarantine product subject to the recall. Additionally, a Response Form was included with the letter for customers to complete and return to the firm. Call 862-703-6730 for questions regarding this recall.
Retiro De Equipo (Recall) de Beuchal Pappas Mobile Bearing Knee System
  • Tipo de evento
    Recall
  • ID del evento
    60138
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0434-2012
  • Fecha de inicio del evento
    2011-09-21
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104504
  • 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
    Prothesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing - Product Code NRA
  • Causa
    On 09/21/2011 endotec, orlando, fl initiated a recall for the beuchel-pappas mobile bearing knee system (bp knee). the bp mobile bearing knee system consists of unapproved mobile (rotating) bearing tibial and patellar components.
  • Acción
    Endotec sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 21, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to examine and quarantine product subject to the recall. Additionally, a Response Form was included with the letter for customers to complete and return to the firm. Call 862-703-6730 for questions regarding this recall.
Retiro De Equipo (Recall) de Beuchal Pappas Mobile Bearing Knee System
  • Tipo de evento
    Recall
  • ID del evento
    60138
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0435-2012
  • Fecha de inicio del evento
    2011-09-21
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104517
  • 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
    Prothesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing - Product Code NRA
  • Causa
    On 09/21/2011 endotec, orlando, fl initiated a recall for the beuchel-pappas mobile bearing knee system (bp knee). the bp mobile bearing knee system consists of unapproved mobile (rotating) bearing tibial and patellar components.
  • Acción
    Endotec sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 21, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to examine and quarantine product subject to the recall. Additionally, a Response Form was included with the letter for customers to complete and return to the firm. Call 862-703-6730 for questions regarding this recall.
Retiro De Equipo (Recall) de BioPro Femoral Head 28 mm 6 mm
  • Tipo de evento
    Recall
  • ID del evento
    60143
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0163-2012
  • Fecha de inicio del evento
    2011-09-21
  • Fecha de publicación del evento
    2011-11-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104523
  • 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
    Prothesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
  • Causa
    Biopro femoral head outer packaging was found lacking proper seal ,compromising sterility.
  • Acción
    Biopro, Inc notified all affected customers via telephone on September 21, 2011 with instructions to quarantine and return affected product to the manufacturer. The firm sent a follow up "RECALL NOTICE" dated September 29, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter gives instructions on how to return affected product. Contact Customer Service at 1-800-252-7707 for questions regarding this recall.
Retiro De Equipo (Recall) de BioPro Femoral Head 28 mm 18
  • Tipo de evento
    Recall
  • ID del evento
    60143
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0164-2012
  • Fecha de inicio del evento
    2011-09-21
  • Fecha de publicación del evento
    2011-11-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104525
  • 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
    Biopro femoral head outer packaging was found lacking proper seal ,compromising sterility.
  • Acción
    Biopro, Inc notified all affected customers via telephone on September 21, 2011 with instructions to quarantine and return affected product to the manufacturer. The firm sent a follow up "RECALL NOTICE" dated September 29, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter gives instructions on how to return affected product. Contact Customer Service at 1-800-252-7707 for questions regarding this recall.
Retiro De Equipo (Recall) de Beuchal Pappas Mobile Bearing Knee System
  • Tipo de evento
    Recall
  • ID del evento
    60138
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0437-2012
  • Fecha de inicio del evento
    2011-09-21
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104957
  • 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
    Prothesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing - Product Code NRA
  • Causa
    On 09/21/2011 endotec, orlando, fl initiated a recall for the beuchel-pappas mobile bearing knee system (bp knee). the bp mobile bearing knee system consists of unapproved mobile (rotating) bearing tibial and patellar components.
  • Acción
    Endotec sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 21, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to examine and quarantine product subject to the recall. Additionally, a Response Form was included with the letter for customers to complete and return to the firm. Call 862-703-6730 for questions regarding this recall.
Retiro De Equipo (Recall) de Beuchal Pappas Mobile Bearing Knee System
  • Tipo de evento
    Recall
  • ID del evento
    60138
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0438-2012
  • Fecha de inicio del evento
    2011-09-21
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104958
  • 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
    Prothesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing - Product Code NRA
  • Causa
    On 09/21/2011 endotec, orlando, fl initiated a recall for the beuchel-pappas mobile bearing knee system (bp knee). the bp mobile bearing knee system consists of unapproved mobile (rotating) bearing tibial and patellar components.
  • Acción
    Endotec sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 21, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to examine and quarantine product subject to the recall. Additionally, a Response Form was included with the letter for customers to complete and return to the firm. Call 862-703-6730 for questions regarding this recall.
Retiro De Equipo (Recall) de Beuchal Pappas Mobile Bearing Knee System
  • Tipo de evento
    Recall
  • ID del evento
    60138
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0439-2012
  • Fecha de inicio del evento
    2011-09-21
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104959
  • 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
    Prothesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing - Product Code NRA
  • Causa
    On 09/21/2011 endotec, orlando, fl initiated a recall for the beuchel-pappas mobile bearing knee system (bp knee). the bp mobile bearing knee system consists of unapproved mobile (rotating) bearing tibial and patellar components.
  • Acción
    Endotec sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 21, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to examine and quarantine product subject to the recall. Additionally, a Response Form was included with the letter for customers to complete and return to the firm. Call 862-703-6730 for questions regarding this recall.
Retiro De Equipo (Recall) de Beuchal Pappas Mobile Bearing Knee System
  • Tipo de evento
    Recall
  • ID del evento
    60138
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0436-2012
  • Fecha de inicio del evento
    2011-09-21
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104955
  • 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
    Prothesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing - Product Code NRA
  • Causa
    On 09/21/2011 endotec, orlando, fl initiated a recall for the beuchel-pappas mobile bearing knee system (bp knee). the bp mobile bearing knee system consists of unapproved mobile (rotating) bearing tibial and patellar components.
  • Acción
    Endotec sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 21, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to examine and quarantine product subject to the recall. Additionally, a Response Form was included with the letter for customers to complete and return to the firm. Call 862-703-6730 for questions regarding this recall.
Retiro De Equipo (Recall) de Beuchal Pappas Mobile Bearing Knee System
  • Tipo de evento
    Recall
  • ID del evento
    60138
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0440-2012
  • Fecha de inicio del evento
    2011-09-21
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104960
  • 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
    Prothesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing - Product Code NRA
  • Causa
    On 09/21/2011 endotec, orlando, fl initiated a recall for the beuchel-pappas mobile bearing knee system (bp knee). the bp mobile bearing knee system consists of unapproved mobile (rotating) bearing tibial and patellar components.
  • Acción
    Endotec sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 21, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to examine and quarantine product subject to the recall. Additionally, a Response Form was included with the letter for customers to complete and return to the firm. Call 862-703-6730 for questions regarding this recall.
Retiro De Equipo (Recall) de Panalock Loop, Lupine Anchor
  • Tipo de evento
    Recall
  • ID del evento
    60287
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0314-2012
  • Fecha de inicio del evento
    2011-10-31
  • Fecha de publicación del evento
    2011-11-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104950
  • 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
    Fastener, fixation, biodegradable, soft tissue - Product Code MAI
  • Causa
    Incorrect suture configuration.
  • Acción
    The firm, DePuy Mitek Inc., sent an "URGENT VOLUNTARY PRODUCT RECALL"letter dated October 31, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to not use or sell any of the identified problem products included in this recall; complete the enclosed business reply form and fax to: 1-508-828-3750 or email to: mitekcomplaints@its.jnj.com (note: It is important that we receive this business reply form, even if you have no product remaining in your inventory from the affected lots); isolate all inventory and call 1-877-379-4871 for return goods authorization and replacement product; and return all identified affected product to: (USA)- DePuy Mitek, ATTN: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324 or (foreign)-GMED Healthcare EDC Quality Dept Rue de Luxembourg 5, ZI Trazegnies, BE-6180 Courcelles, Belgium. If you have any questions or concerns with regard to this program, please contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-877-379-4871.
Retiro De Equipo (Recall) de Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive
  • Tipo de evento
    Recall
  • ID del evento
    60237
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0348-2012
  • Fecha de inicio del evento
    2011-10-17
  • Fecha de publicación del evento
    2011-12-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104849
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Causa
    The potential exists for the large oscillating saw attachment to disengage from the small battery drive handpiece. if the attachment disengages from the handpiece, there is a potential for injury to the patient and/or user.
  • Acción
    Synthes sent a "NOTICE: MEDICAL DEVICE RECALL" letter dated October 17, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The firm requests that customers return their affected device(s) for servicing. Instructions are provided for customers to follow. Customers having questions regarding this notice should contact the firm at 610-719-5450.
Retiro De Equipo (Recall) de Lupine Loop Plus w/ Orthocord
  • Tipo de evento
    Recall
  • ID del evento
    60287
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0315-2012
  • Fecha de inicio del evento
    2011-10-31
  • Fecha de publicación del evento
    2011-11-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104951
  • 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
    Fastener, fixation, biodegradable, soft tissue - Product Code MAI
  • Causa
    Incorrect suture configuration.
  • Acción
    The firm, DePuy Mitek Inc., sent an "URGENT VOLUNTARY PRODUCT RECALL"letter dated October 31, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to not use or sell any of the identified problem products included in this recall; complete the enclosed business reply form and fax to: 1-508-828-3750 or email to: mitekcomplaints@its.jnj.com (note: It is important that we receive this business reply form, even if you have no product remaining in your inventory from the affected lots); isolate all inventory and call 1-877-379-4871 for return goods authorization and replacement product; and return all identified affected product to: (USA)- DePuy Mitek, ATTN: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324 or (foreign)-GMED Healthcare EDC Quality Dept Rue de Luxembourg 5, ZI Trazegnies, BE-6180 Courcelles, Belgium. If you have any questions or concerns with regard to this program, please contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-877-379-4871.
Retiro De Equipo (Recall) de Lupine Loop Plus w/ Orthocord DS
  • Tipo de evento
    Recall
  • ID del evento
    60287
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0316-2012
  • Fecha de inicio del evento
    2011-10-31
  • Fecha de publicación del evento
    2011-11-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104952
  • 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
    Fastener, fixation, biodegradable, soft tissue - Product Code MAI
  • Causa
    Incorrect suture configuration.
  • Acción
    The firm, DePuy Mitek Inc., sent an "URGENT VOLUNTARY PRODUCT RECALL"letter dated October 31, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to not use or sell any of the identified problem products included in this recall; complete the enclosed business reply form and fax to: 1-508-828-3750 or email to: mitekcomplaints@its.jnj.com (note: It is important that we receive this business reply form, even if you have no product remaining in your inventory from the affected lots); isolate all inventory and call 1-877-379-4871 for return goods authorization and replacement product; and return all identified affected product to: (USA)- DePuy Mitek, ATTN: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324 or (foreign)-GMED Healthcare EDC Quality Dept Rue de Luxembourg 5, ZI Trazegnies, BE-6180 Courcelles, Belgium. If you have any questions or concerns with regard to this program, please contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-877-379-4871.
Retiro De Equipo (Recall) de Foundation Tibial Broach
  • Tipo de evento
    Recall
  • ID del evento
    60245
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0349-2012
  • Fecha de inicio del evento
    2011-10-26
  • Fecha de publicación del evento
    2011-12-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104897
  • 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
    The strike plate may dislodge from the broach stem handle during impaction of the device.
  • Acción
    DJO Global sent an URGENT FIELD SAFETY NOTICE letter dated October 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the information to all those who need to be aware within their organization or to any organization where the affected devices have been transferred. Customers should contact Customer Service to place a replacement order and receive an RMA number and return all affected devices using the RMA number. For any questions call (512) 834-6255.
  • « First
  • ‹ Prev
  • 1
  • 2
  • 3
  • 4
  • 5
  • …
  • Next ›
  • Last »

Acerca de la base de datos

Explore más de 120,000 registros de retiros, alertas y notificaciones de seguridad de dispositivos médicos y sus conexiones con los fabricantes.

  • Preguntas frecuentes
  • Acerca de la base de datos
  • Contáctenos
  • Créditos

Historias en su correo

¿Trabaja en la industria médica? ¿O tiene experiencia con algún dispositivo médico? Nuestra reportería no ha terminado. Queremos oír de usted.

¡Cuéntanos tu historia!

Aviso

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.

Descargar la data

La International Medical Devices Database está bajo la licencia Open Database License y sus contenidos bajo la licencia Creative Commons Attribution-ShareAlike . Al usar esta data, siempre citar al International Consortium of Investigative Journalists. Puede descargar acá una copia de la base de datos.

Descargar todo (zipped)