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  • Dispositivo 1211
  • Fabricante 31827
  • Evento 5885
  • Implante 4142
Retiro De Equipo (Recall) de M / L cones with femoral stems and modular necks Kinectiv
  • Tipo de evento
    Recall
  • ID del evento
    201506916
  • Fecha
    2015-06-10
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/cones-m-l-avec-tiges-femorales-et-cols-modulaires-kinectiv-zimmer-rappel-de-lots
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    The ANSM has been informed of the implementation of a lot withdrawal carried out by ZIMMER INC. The users concerned have received the attached mail (10/06/2015) (90 KB). This safety action is registered with the ANSM under the number 201506916. You will be able to consult its status on the Directory of Materiovigilance Reports (01/01/1970) (0 ko) by entering this registration number.
Retiro De Equipo (Recall) de PROFEMUR VAR / VAL LONG CoCr Modular Collar
  • Tipo de evento
    Recall
  • ID del evento
    201510797
  • Fecha
    2015-08-27
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/col-modulaire-profemur-var-val-long-cocr-microport-orthopedics-rappel
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    ANSM has been informed of the implementation of a lot withdrawal carried out by MICROPORT ORTHOPEDICS. The users concerned have received the attached mail (27/08/2015) (673 KB). This security action is registered at ANSM under the number 201510797. You will be able to check its status on the Directory of Materiovigilance Reports by entering this registration number.
Retiro De Equipo (Recall) de Ptg Advance Non-cemented Tibial Headplates
  • Tipo de evento
    Recall
  • ID del evento
    R1605237
  • Fecha
    2016-07-21
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/orthopedie-embases-tibiales-non-cimentees-de-la-ptg-advance-microport-orthopedics-rappel-de-produit
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    The ANSM has been informed of the implementation of a product withdrawal action carried out by the company MICROPORT ORTHOPEDICS .. The users concerned have received the attached mail (21/07/2016) (539 KB). This safety action is registered with the ANSM under the number R1605237.
Retiro De Equipo (Recall) de Standard Offset Cup Impactor with POM-C Handle
  • Tipo de evento
    Recall
  • ID del evento
    R1607499
  • Fecha
    2016-08-24
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/materiel-ancillaire-d-orthopedie-impacteur-de-cupule-decale-standard-avec-poignee-en-pom-c-greatbatch-medical-rappel
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    The ANSM has been informed of the implementation of a product withdrawal action carried out by Greatbatch Medical. The users concerned have received the attached mail (24/08/2016) (148 KB). This safety action is registered with the ANSM under the number R1607499.
Retiro De Equipo (Recall) de Inverted Shoulder Total Prosthesis Tray
  • Tipo de evento
    Recall
  • ID del evento
    R1702472
  • Fecha
    2017-03-10
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/prothese-d-epaule-orthopedie-plateau-de-prothese-totale-d-epaule-inversee-article-115340-zimmer-biomet-rappel-de-lot
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    The ANSM has been informed of the implementation of a lot withdrawal action carried out by the company BIOMET. The users concerned have received the attached mail (10/03/2017) (317 KB). This safety action is registered with the ANSM under the number R1702472.
Retiro De Equipo (Recall) de Oasys Midline Spine Surgery Plates
  • Tipo de evento
    Recall
  • Fecha
    2013-06-04
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/plaques-oasys-midline-pour-chirurgie-du-rachis-stryker-rappel-de-produit
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    ANSM has been informed of the implementation of a recall made by Stryker. The users concerned have received the attached mail. (04/06/2013) (70 KB)
Retiro De Equipo (Recall) de Device Recall Trilogy Bone Screws
  • Tipo de evento
    Recall
  • ID del evento
    69851
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0824-2015
  • Fecha de inicio del evento
    2014-11-21
  • Fecha de publicación del evento
    2014-12-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131707
  • 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
    Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures. .
  • Acción
    Zimmer sent an Urgent Medical Device Recall letter dated November 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel were aware of the contents. Customers were advised to quarantine any affected product and notify their Zimmer sales representative who will remove the recalled product from their facility. For patients who previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
Retiro De Equipo (Recall) de Device Recall NexGen Complete Knee Solution Monoblock Tibial Provis...
  • Tipo de evento
    Recall
  • ID del evento
    69866
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0851-2015
  • Fecha de inicio del evento
    2014-12-02
  • Fecha de publicación del evento
    2014-12-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131726
  • 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
    Probe - Product Code HXB
  • Causa
    During cleaning, two separate units of the nexgen tibial base plates did not fit with the tibial base plate handle.
  • Acción
    Zimmer, Inc. sent recall letters/ hospital risk managers emails and letters via courier service on December 2, 2014. Inventory Return Certification Forms were also provided. Your responsibilities are: 1. Locate all products from the identified lot above and quarantine them immediately. 2. Carry out a physical count of all affected product in your territory and complete the Inventory Return Certification Form (Attachment 1), and email a completed copy of Attachment 1 to corporatequality.postmarket@zimmer.com. 3. Return the recalled product along with the completed Inventory Return Certification Form (Attachment 1) to the specified address. 4. Please note that any hospitals that received direct shipments of this product from Zimmer will be sent a copy of the Risk Manager letter directly. 5. Please notify Zimmer of any hospitals that you have further distributed the affected product to. Supply the information for any hospitals that you have identified, as well as the affected surgeons using the provided spreadsheet template. Zimmer will notify the additional surgeons and hospitals you identify via Fed Ex mailing. The template will be emailed to you for completion and return to corporatequality.postmarket@zimmer.com. 6. Ensure that a copy of the Risk Managers letter is left with the facilities from which product is removed by providing them with a copy of the letter, if they are not identified as a facility receiving a letter directly from Zimmer. 7. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST. Biomet emailed a new letter with correct distribution dates on 1/16/2015.
Retiro De Equipo (Recall) de Device Recall Conformis iTotal CR G2 Knee Replacement System
  • Tipo de evento
    Recall
  • ID del evento
    69867
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0581-2015
  • Fecha de inicio del evento
    2014-11-19
  • Fecha de publicación del evento
    2014-12-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131727
  • 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
    Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting.
  • Acción
    Conformis notified the consignee by telephone on 11/19/14, about the problem. A sales representative visited the site and retrieved the device.
Retiro De Equipo (Recall) de Device Recall The HemiCAP Contoured Articular Prosthetic
  • Tipo de evento
    Recall
  • ID del evento
    69723
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1110-2015
  • Fecha de inicio del evento
    2014-11-24
  • Fecha de publicación del evento
    2015-02-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131823
  • 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, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
  • Causa
    Fully threaded taper post fixation components not cleared for marketing in the us with current indications.
  • Acción
    Arthosurface sent an Urgent Medical Device Recall letter on November 24, 2014 via UPS, to all affected customers. The letter informed consignees of the recall and asked them to return two completed forms, 1. Acknowledgement & Receipt Form and 2. Inventory Record via fax, email, or mail. Customers with questions were instcted to contact their local sales representatiave or email RA@arthrosurface.com. For questions regarding this recall call 508-528-4604.
Retiro De Equipo (Recall) de Device Recall The HemiCAP Contoured Articular Prosthetic
  • Tipo de evento
    Recall
  • ID del evento
    69723
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1111-2015
  • Fecha de inicio del evento
    2014-11-24
  • Fecha de publicación del evento
    2015-02-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131834
  • 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, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
  • Causa
    Fully threaded taper post fixation components not cleared for marketing in the us with current indications.
  • Acción
    Arthosurface sent an Urgent Medical Device Recall letter on November 24, 2014 via UPS, to all affected customers. The letter informed consignees of the recall and asked them to return two completed forms, 1. Acknowledgement & Receipt Form and 2. Inventory Record via fax, email, or mail. Customers with questions were instcted to contact their local sales representatiave or email RA@arthrosurface.com. For questions regarding this recall call 508-528-4604.
Retiro De Equipo (Recall) de Device Recall Xpress System Pedicle Screw Assembly, 5.5 x 55mm
  • Tipo de evento
    Recall
  • ID del evento
    70774
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1512-2015
  • Fecha de inicio del evento
    2015-03-11
  • Fecha de publicación del evento
    2015-04-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134646
  • 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
    Orthosis, spondylolisthesis spinal fixation - Product Code MNH
  • Causa
    One lot of instruments have etched on the yoke of the pedicle screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.
  • Acción
    The firm, X-spine Systems, Inc., sent an "Urgent Medical Device Recall" letter dated March 19, 2015 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to notify affected hospital and surgeon of the recall immediately; complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately via mail: 725 Alexandersville Road, Miamisburg OH 45342-RMA #5288; and No action should be taken with product that has been implanted. Please contact customer service at 800.903.0640 or email orders@x-spine.com with any questions.
Retiro De Equipo (Recall) de Device Recall The HemiCAP Contoured Articular Prosthetic
  • Tipo de evento
    Recall
  • ID del evento
    69723
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1112-2015
  • Fecha de inicio del evento
    2014-11-24
  • Fecha de publicación del evento
    2015-02-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131836
  • 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, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
  • Causa
    Fully threaded taper post fixation components not cleared for marketing in the us with current indications.
  • Acción
    Arthosurface sent an Urgent Medical Device Recall letter on November 24, 2014 via UPS, to all affected customers. The letter informed consignees of the recall and asked them to return two completed forms, 1. Acknowledgement & Receipt Form and 2. Inventory Record via fax, email, or mail. Customers with questions were instcted to contact their local sales representatiave or email RA@arthrosurface.com. For questions regarding this recall call 508-528-4604.
Retiro De Equipo (Recall) de Device Recall The HemiCAP Contoured Articular Prosthetic
  • Tipo de evento
    Recall
  • ID del evento
    69723
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1113-2015
  • Fecha de inicio del evento
    2014-11-24
  • Fecha de publicación del evento
    2015-02-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131837
  • 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, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
  • Causa
    Fully threaded taper post fixation components not cleared for marketing in the us with current indications.
  • Acción
    Arthosurface sent an Urgent Medical Device Recall letter on November 24, 2014 via UPS, to all affected customers. The letter informed consignees of the recall and asked them to return two completed forms, 1. Acknowledgement & Receipt Form and 2. Inventory Record via fax, email, or mail. Customers with questions were instcted to contact their local sales representatiave or email RA@arthrosurface.com. For questions regarding this recall call 508-528-4604.
Retiro De Equipo (Recall) de Device Recall The HemiCAP Contoured Articular Prosthetic
  • Tipo de evento
    Recall
  • ID del evento
    69723
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1114-2015
  • Fecha de inicio del evento
    2014-11-24
  • Fecha de publicación del evento
    2015-02-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131839
  • 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, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
  • Causa
    Fully threaded taper post fixation components not cleared for marketing in the us with current indications.
  • Acción
    Arthosurface sent an Urgent Medical Device Recall letter on November 24, 2014 via UPS, to all affected customers. The letter informed consignees of the recall and asked them to return two completed forms, 1. Acknowledgement & Receipt Form and 2. Inventory Record via fax, email, or mail. Customers with questions were instcted to contact their local sales representatiave or email RA@arthrosurface.com. For questions regarding this recall call 508-528-4604.
Retiro De Equipo (Recall) de Device Recall Gentle Threads
  • Tipo de evento
    Recall
  • ID del evento
    71526
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1945-2015
  • Fecha de inicio del evento
    2015-06-03
  • Fecha de publicación del evento
    2015-07-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138107
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    Part number: 905620 lot: 824610 gentle threads interference screw 10x25mm round head is mixed with the part number: 905627 lot: 753410 gentle threads interference screw 9x35mm full thread. if the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.
  • Acción
    On 6/3/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for locating and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Retiro De Equipo (Recall) de Device Recall Osteobond Copolymer Bone Cement
  • Tipo de evento
    Recall
  • ID del evento
    69904
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0900-2015
  • Fecha de inicio del evento
    2014-12-08
  • Fecha de publicación del evento
    2014-12-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131930
  • 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
    Bone cement - Product Code LOD
  • Causa
    Samples of product from supplier lot 14d0809 and 14d0808 showed little adhesive transfer between the tyvek lid and cavity when opened for internal bone cement cure and pairing tests. visually these samples do not meet the requirements of zwi 43.109 and corresponding visual aid 55-0000-310-01.
  • Acción
    "Urgent Medical Device Recall - Lot Specific" notifications will be sent to the affected distributors, surgeons, and hospital risk managers with instructions for returning the affected product. The letters identified the affected product, reason for recall, risks, and responsibilities. Customers are to complete and return the Inventory Return Certification Form along with the affected product. Questions should be directed to the customer call at 1-800-348-2759.
Retiro De Equipo (Recall) de Device Recall Persona Cemented Tibial Broach Inserter/Extractor
  • Tipo de evento
    Recall
  • ID del evento
    69906
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0853-2015
  • Fecha de inicio del evento
    2014-12-04
  • Fecha de publicación del evento
    2014-12-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131934
  • 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 affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. zimmer received one complaint indicating the magnet cover of a persona cemented tibial broach inserter/extractor handle lot 62085420 was missing after broaching the tibia. postoperative radiographs were inspected and the magnet cover was not identified. the investigation indi.
  • Acción
    Notifications will be sent to the affected distributors and hospital risk managers with instructions for returning the affected product the week of December 8, 2014. Recalled product will be quarantined and returned to Zimmer Sales Representatives to be destroyed. The public contact for the recall is: Consumer Relations Call Center Zimmer, Inc. P O Box 708 Warsaw, IN 46581-0708 consumer@zimmer.com Phone: 1-800-447-5633 Fax: 574-371-8755
Retiro De Equipo (Recall) de Device Recall Palacos R
  • Tipo de evento
    Recall
  • ID del evento
    25497
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0546-03
  • Fecha de inicio del evento
    2003-01-17
  • Fecha de publicación del evento
    2003-02-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-09-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25929
  • 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
    Bone Cement - Product Code LOD
  • Causa
    There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer.
  • Acción
    The firm issued recall letter for one lot dated January 21, 2003, but a subsequent letter dated January 21, 2003 expanded the recall to all lots. Customers are instructed to not use the product. They are to either return it to their local distributor, or to mix the cement and properly dispose of it themselves. [This is a hazardous material requiring special shipping methods.]
Retiro De Equipo (Recall) de Device Recall T2
  • Tipo de evento
    Recall
  • ID del evento
    25585
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0584-03
  • Fecha de inicio del evento
    2003-01-20
  • Fecha de publicación del evento
    2003-02-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-05-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26106
  • 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
    Bit, Drill - Product Code HTW
  • Causa
    Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
  • Acción
    Howmedica sent notification letters and product accountability forms to all branches/agents via FedEx with return receipt. To Hospitals, notifications letters were sent to OR Supervisors via FedEx with return receipts.
Retiro De Equipo (Recall) de Device Recall ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    69963
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1029-2015
  • Fecha de inicio del evento
    2014-12-05
  • Fecha de publicación del evento
    2015-01-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132050
  • 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
    Intraoperative orthopedic joint assessment aid - Product Code ONN
  • Causa
    Presence of one inoperable (dead) sensor pad.
  • Acción
    OrthoSensor sent an Recall letter dated December 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required Action for Users " Remove the above-referenced serial numbers from your VERASENSE inventory and quarantine. " Complete the enclosed Customer Response Form. Actions to be taken by OrthoSensor " You will be credited for these devices for your full purchase amount. The Returned Materials Authorization (RMA) number for each device in your possession is listed above. " OrthoSensor will replenish these devices as soon as they are available. For further questions please call (954) 577-7770.
Retiro De Equipo (Recall) de Device Recall Sirius Polish Cemented Stem 34B
  • Tipo de evento
    Recall
  • ID del evento
    69932
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0822-2015
  • Fecha de inicio del evento
    2014-12-02
  • Fecha de publicación del evento
    2014-12-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131996
  • 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
    After receiving a complaint, biomet orthopedic inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: sirius polish cemented stem 34b catalog number: 51-199333, lot number identification: 024320 and sirius polish cemented stem 38c, catalog number: 51-199335, lot number identification: 141680, 180920.
  • Acción
    Sent notices to customers dated 12/2/2014 notifying them of the recall: 5 were implanted, 3 were shipped to subsidiary for testing, and 2 are in Biomet control. Public Contact for the recall is: Audrey Daenzer, Field Action Specialist, Regulatory Compliance audrey.daenzer@biomet.com, can be contacted from Monday through Friday 8 AM to 5 PM, 574-372-1570.
Retiro De Equipo (Recall) de Device Recall Sirius Polish Cemented Stem 34B
  • Tipo de evento
    Recall
  • ID del evento
    69932
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0823-2015
  • Fecha de inicio del evento
    2014-12-02
  • Fecha de publicación del evento
    2014-12-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131997
  • 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
    After receiving a complaint, biomet orthopedic inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: sirius polish cemented stem 348 catalog number: 51-199333, lot number identification: 024320 and sirius polish cemented stem 38c, catalog number: 51-199335, lot number identification: 141680, 180920.
  • Acción
    Sent notices to customers dated 12/2/2014 notifying them of the recall: 5 were implanted, 3 were shipped to subsidiary for testing, and 2 are in Biomet control. Public Contact for the recall is: Audrey Daenzer, Field Action Specialist, Regulatory Compliance audrey.daenzer@biomet.com, can be contacted from Monday through Friday 8 AM to 5 PM, 574-372-1570.
Retiro De Equipo (Recall) de Device Recall SolitaireC Cervical Spacer System
  • Tipo de evento
    Recall
  • ID del evento
    69981
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0874-2015
  • Fecha de inicio del evento
    2014-11-11
  • Fecha de publicación del evento
    2014-12-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132064
  • 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 integrated fixation, cervical - Product Code OVE
  • Causa
    A design deficiency was discovered whereby the drill/awl sleeve and spring-loaded drill/awl sleeve instruments (the sleeves) allow the mating drill and awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.
  • Acción
    The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated 11/11/2014 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and remove from circulation the items consigned/loaned to your account as identified; carefully follow the instructions on the enclosed "Response Form"; complete and return Response Form via fax to 303.501.8444, and if you have further distributed these items to medical facilities, you MUST notify them of the actions. Questions related to this notice should be directed to the Sr. Quality Engineer at 518-859-3487 Monday through Friday, 8 am to 4 pm ET.
Retiro De Equipo (Recall) de Device Recall BIOLOX delta TS Ceramic Femoral Head Articul/eze 12/1...
  • Tipo de evento
    Recall
  • ID del evento
    69984
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0825-2015
  • Fecha de inicio del evento
    2014-11-07
  • Fecha de publicación del evento
    2014-12-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132067
  • 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
    Two complaints reported that the biolox delta ts ceramic femoral articul/eze12/14 36mm +12 head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. the loosening refers to tissue tension and not the taper connection between the femoral head and stem. the investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the.
  • Acción
    On 11/7/2014, URGENT INFORMATION - RECALL NOTICE notifications were sent to the affected distributors, hospitals, and doctors with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospitals and doctors were notified via sales consultant visit. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc. Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. - 5 p.m. EDT). For questions about device recall information provided, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EDT).
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