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  • Dispositivo 5
  • Fabricante 3
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Device Recall Plasma Chemical Indicator
  • Tipo de evento
    Recall
  • ID del evento
    52777
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1532-2010
  • Fecha de inicio del evento
    2009-07-15
  • Fecha de publicación del evento
    2010-04-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-06-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85106
  • 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
    Plasma Chemical Indicator - Product Code JOJ
  • Causa
    This action notifies affected steritec customers as well as private label distributors of the necessity to modify the shelf life of their products. there is insufficient data on file to support the shelf life dating on the product labeling.
  • Acción
    Notify accounts by e-mail and letter, offering to exchange product for product with revised expiration date. Products exhausted by proper expiration date need not be returned or relabeled. Questions are directed to the firm at (303) 660-4201.
Retiro De Equipo (Recall) de Device Recall Dimension Vista System CHEM 1 CAL, Catalog Number KC110
  • Tipo de evento
    Recall
  • ID del evento
    53323
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0864-2010
  • Fecha de inicio del evento
    2009-08-31
  • Fecha de publicación del evento
    2010-02-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85268
  • 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
    Calibrator, multi-analyte mixture - Product Code JIX
  • Causa
    Siemens healthcare diagnostics, inc. has confirmed high accuracy shifts with dimension vista urca flex reagent cartridge (various lots) when calibrating with some vials from chem 1 calibrator lot 9dm001.
  • Acción
    An Urgent Field Safety Notice dated August 31, 2009, was issued to all affected customers. Customers were instructed to discontinue the use of Dimension Vista System CHEM 1 Cal lot 9DM001 and discard any remaining product. If customers have any question they can contact Technical Solutions at 1-800-241-0420.
Retiro De Equipo (Recall) de Device Recall PT100/PT Link Waterbath
  • Tipo de evento
    Recall
  • ID del evento
    53336
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0287-2013
  • Fecha de inicio del evento
    2008-05-01
  • Fecha de publicación del evento
    2012-11-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85291
  • 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
    Bath, flotation, tissue - Product Code IDY
  • Causa
    Dako is recalling the pt link waterbath because of a possible electrical hazard. specifically, if the heater pad under the reagent tank becomes wet, it may present an electrical shock hazard when the lid is open.
  • Acción
    The firm, Dako, sent a "DAKO PT LINK ADVISORY NOTICE" dated May 1, 2008 to customers who purchased the PT Waterbath along with a customer acknowledgement document informing the users of the potential electrical hazard. The notice described the product, problem and actions to be taken. The customers were instructed to follow the attached Safety Instructions; place the enclosed warning labels directly on the instrument as shown in the attached instructions and adhere to the warning labels as described. Customers with questions were instructed to call Dako Products' Technical Support at (800) 424-0021.
Retiro De Equipo (Recall) de Device Recall Huber Plus NonCoring Needle Safety Infusion Set
  • Tipo de evento
    Recall
  • ID del evento
    53341
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0861-2010
  • Fecha de inicio del evento
    2010-01-14
  • Fecha de publicación del evento
    2010-02-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-05-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85298
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury.
  • Acción
    Bard Access Systems, Inc. issued and "Urgent: Huber Plus Non-Coring Needle Safety Infusion Set Recall" notification beginning January 2010. Users were instructed to quarantine all affected product and to notify any of their customers that had received the product. Quarantined product is to be returned to the firm. For further information, contact Bard Access Systems, Inc. at 1-800-290-1689.
Retiro De Equipo (Recall) de Device Recall Koodinat M/MP Patient Table used with Angiostar
  • Tipo de evento
    Recall
  • ID del evento
    53353
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0166-2010
  • Fecha de inicio del evento
    2009-07-01
  • Fecha de publicación del evento
    2009-11-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-01-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85317
  • 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
    System, x-ray, angiographic - Product Code IZI
  • Causa
    The table swivel locking mechanism may not completely engage adn could result in uncontrolled patient movement during transfer resulting in a patient fall.
  • Acción
    The recalling firm issued a Customer Safety Advisory Notice dated July 1, 2009 to affected customers via Update Instructions AX025/09/S to inform customer of the potential issues and provide instructions to prevent occurrence. The firm also provided an addendum to User Manual. Direct questions about the recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300.
Retiro De Equipo (Recall) de Device Recall Koodinat M/MP Patient Table used with Multistar
  • Tipo de evento
    Recall
  • ID del evento
    53353
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0167-2010
  • Fecha de inicio del evento
    2009-07-01
  • Fecha de publicación del evento
    2009-11-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-01-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85318
  • 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
    System, x-ray, angiographic - Product Code IZI
  • Causa
    The table swivel locking mechanism may not completely engage and could result in uncontrolled patient movement during transfer resulting in a patient fall.
  • Acción
    The recalling firm issued a Customer Safety Advisory Notice dated July 1, 2009 to affected customers via Update Instructions AX025/09/S to inform customer of the potential issues and provide instructions to prevent occurrence. The firm also provided an addendum to User Manual. Direct questions about the recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300.
Retiro De Equipo (Recall) de Device Recall Zimmer Natural Nail System, Antegrade Femoral Interlo...
  • Tipo de evento
    Recall
  • ID del evento
    52806
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0382-2010
  • Fecha de inicio del evento
    2009-07-01
  • Fecha de publicación del evento
    2009-11-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85319
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.
  • Acción
    On July 1, 2009, U.S. distributors were notified by e-mail to return two instruments. The recall was expanded with international accounts notified by e-mail on August 5, 2009, and U.S. accounts being notified by e-mail on August 6, 2009, to return 7 instruments. The scope of the recall was then expanded again to include 14 instruments and another letter dated September 14, 2009 to distributors and user accounts. The notifications described the affected products, problem, health risks and actions for consignees. Direct questions about the recall to Zimmer, Inc. by calling 1-800-613-6131.
Retiro De Equipo (Recall) de Device Recall Zimmer Dental Torque Wrench
  • Tipo de evento
    Recall
  • ID del evento
    53430
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1212-2010
  • Fecha de inicio del evento
    2009-01-19
  • Fecha de publicación del evento
    2010-03-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85491
  • 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
    torque wrench - Product Code DZE
  • Causa
    Pro-dex has initiated a recall on their dental torque wrench. the recall was initiated due to an inaccurate laser etch identification of the torque value.
  • Acción
    A "Voluntary Firm Initiated Recall" letter dated January 22, 2009, was sent to the customer. The letter describes the product, problem and action to be taken by the customer. The customer should immediately cease distribution or use of the noted lot; evaluate inventory and distribution records to ensure that this lot is removed from any potential point of use, and return the product to Returns Department at Pro-Dex, Inc . and include the RMA number on the shipping box. If you have any questions or concerns regarding this matter, please call (949) 769-3200.
Retiro De Equipo (Recall) de Device Recall Zimmer Natural Nail System, Antegrade Femoral Recon M...
  • Tipo de evento
    Recall
  • ID del evento
    52806
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0383-2010
  • Fecha de inicio del evento
    2009-07-01
  • Fecha de publicación del evento
    2009-11-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85320
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.
  • Acción
    On July 1, 2009, U.S. distributors were notified by e-mail to return two instruments. The recall was expanded with international accounts notified by e-mail on August 5, 2009, and U.S. accounts being notified by e-mail on August 6, 2009, to return 7 instruments. The scope of the recall was then expanded again to include 14 instruments and another letter dated September 14, 2009 to distributors and user accounts. The notifications described the affected products, problem, health risks and actions for consignees. Direct questions about the recall to Zimmer, Inc. by calling 1-800-613-6131.
Retiro De Equipo (Recall) de Device Recall Zimmer Natural Nail System, Antegrade Femoral Interlo...
  • Tipo de evento
    Recall
  • ID del evento
    52806
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0384-2010
  • Fecha de inicio del evento
    2009-07-01
  • Fecha de publicación del evento
    2009-11-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85321
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.
  • Acción
    On July 1, 2009, U.S. distributors were notified by e-mail to return two instruments. The recall was expanded with international accounts notified by e-mail on August 5, 2009, and U.S. accounts being notified by e-mail on August 6, 2009, to return 7 instruments. The scope of the recall was then expanded again to include 14 instruments and another letter dated September 14, 2009 to distributors and user accounts. The notifications described the affected products, problem, health risks and actions for consignees. Direct questions about the recall to Zimmer, Inc. by calling 1-800-613-6131.
Retiro De Equipo (Recall) de Device Recall Zimmer Natural Nail System, Antegrade Femoral Interlo...
  • Tipo de evento
    Recall
  • ID del evento
    52806
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0385-2010
  • Fecha de inicio del evento
    2009-07-01
  • Fecha de publicación del evento
    2009-11-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85322
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.
  • Acción
    On July 1, 2009, U.S. distributors were notified by e-mail to return two instruments. The recall was expanded with international accounts notified by e-mail on August 5, 2009, and U.S. accounts being notified by e-mail on August 6, 2009, to return 7 instruments. The scope of the recall was then expanded again to include 14 instruments and another letter dated September 14, 2009 to distributors and user accounts. The notifications described the affected products, problem, health risks and actions for consignees. Direct questions about the recall to Zimmer, Inc. by calling 1-800-613-6131.
Retiro De Equipo (Recall) de Device Recall Zimmer Natural Nail System, Antegrade Femoral Recon M...
  • Tipo de evento
    Recall
  • ID del evento
    52806
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0386-2010
  • Fecha de inicio del evento
    2009-07-01
  • Fecha de publicación del evento
    2009-11-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85323
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.
  • Acción
    On July 1, 2009, U.S. distributors were notified by e-mail to return two instruments. The recall was expanded with international accounts notified by e-mail on August 5, 2009, and U.S. accounts being notified by e-mail on August 6, 2009, to return 7 instruments. The scope of the recall was then expanded again to include 14 instruments and another letter dated September 14, 2009 to distributors and user accounts. The notifications described the affected products, problem, health risks and actions for consignees. Direct questions about the recall to Zimmer, Inc. by calling 1-800-613-6131.
Retiro De Equipo (Recall) de Device Recall Zimmer Natural Nail System, Antegrade Femoral Tibial ...
  • Tipo de evento
    Recall
  • ID del evento
    52806
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0387-2010
  • Fecha de inicio del evento
    2009-07-01
  • Fecha de publicación del evento
    2009-11-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85324
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.
  • Acción
    On July 1, 2009, U.S. distributors were notified by e-mail to return two instruments. The recall was expanded with international accounts notified by e-mail on August 5, 2009, and U.S. accounts being notified by e-mail on August 6, 2009, to return 7 instruments. The scope of the recall was then expanded again to include 14 instruments and another letter dated September 14, 2009 to distributors and user accounts. The notifications described the affected products, problem, health risks and actions for consignees. Direct questions about the recall to Zimmer, Inc. by calling 1-800-613-6131.
Retiro De Equipo (Recall) de Device Recall Zimmer Natural Nail System, Connecting Knob
  • Tipo de evento
    Recall
  • ID del evento
    52806
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0388-2010
  • Fecha de inicio del evento
    2009-07-01
  • Fecha de publicación del evento
    2009-11-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85325
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.
  • Acción
    On July 1, 2009, U.S. distributors were notified by e-mail to return two instruments. The recall was expanded with international accounts notified by e-mail on August 5, 2009, and U.S. accounts being notified by e-mail on August 6, 2009, to return 7 instruments. The scope of the recall was then expanded again to include 14 instruments and another letter dated September 14, 2009 to distributors and user accounts. The notifications described the affected products, problem, health risks and actions for consignees. Direct questions about the recall to Zimmer, Inc. by calling 1-800-613-6131.
Retiro De Equipo (Recall) de Device Recall automated external defibrillator
  • Tipo de evento
    Recall
  • ID del evento
    53383
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0063-2010
  • Fecha de inicio del evento
    2009-10-01
  • Fecha de publicación del evento
    2009-12-08
  • 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=85372
  • 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
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • Causa
    A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.
  • Acción
    On September 28, 2009 Philips issued a nationwide press release. On October 1, 2009 the firm issued notification letters to consignees arranging for the return and replacement of the affected units. The firm also set up a page on their website with a serial number look-up tool. For further information or support concerning this issue, customers are asked to contact Philips at 1.800.263.3342 or visit www.philips.com/FR2PlusAction for the serial number look-up list, answers to frequently asked questions, directions for the battery insertion test, and the replacement AED selection form.
Retiro De Equipo (Recall) de Device Recall Accolade System Surgical Technique
  • Tipo de evento
    Recall
  • ID del evento
    53386
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0504-2010
  • Fecha de inicio del evento
    2009-08-31
  • Fecha de publicación del evento
    2010-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85381
  • 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
    Surgical Literature - Product Code LZO
  • Causa
    Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.
  • Acción
    "Urgent Product Correction - Surgical Protocol" letters and Product Accountability Forms were sent to consignees via Fed Ex on August 31, 2009 and September 1, 2009 with return receipt. Notification letters described the issue, protocols affected, potential hazard and harm and risk mitigation. Direct questions about the recall by calling 1-201-972-2100 or Customer Service 1 -866-OR-ASSIST (1 -866-672-7747).
Retiro De Equipo (Recall) de Device Recall CuttingEdge Total Hip Instrumentation Surgical Protocol
  • Tipo de evento
    Recall
  • ID del evento
    53386
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0505-2010
  • Fecha de inicio del evento
    2009-08-31
  • Fecha de publicación del evento
    2010-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85397
  • 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
    Surgical Literature - Product Code LZO
  • Causa
    Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.
  • Acción
    "Urgent Product Correction - Surgical Protocol" letters and Product Accountability Forms were sent to consignees via Fed Ex on August 31, 2009 and September 1, 2009 with return receipt. Notification letters described the issue, protocols affected, potential hazard and harm and risk mitigation. Direct questions about the recall by calling 1-201-972-2100 or Customer Service 1 -866-OR-ASSIST (1 -866-672-7747).
Retiro De Equipo (Recall) de Device Recall OmniFit Eon
  • Tipo de evento
    Recall
  • ID del evento
    53386
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0506-2010
  • Fecha de inicio del evento
    2009-08-31
  • Fecha de publicación del evento
    2010-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85400
  • 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
    Surgical Literature - Product Code LZO
  • Causa
    Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.
  • Acción
    "Urgent Product Correction - Surgical Protocol" letters and Product Accountability Forms were sent to consignees via Fed Ex on August 31, 2009 and September 1, 2009 with return receipt. Notification letters described the issue, protocols affected, potential hazard and harm and risk mitigation. Direct questions about the recall by calling 1-201-972-2100 or Customer Service 1 -866-OR-ASSIST (1 -866-672-7747).
Retiro De Equipo (Recall) de Device Recall OnmiFit HFx Surgical Protocol
  • Tipo de evento
    Recall
  • ID del evento
    53386
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0507-2010
  • Fecha de inicio del evento
    2009-08-31
  • Fecha de publicación del evento
    2010-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85401
  • 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
    Surgical Literature - Product Code LZO
  • Causa
    Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.
  • Acción
    "Urgent Product Correction - Surgical Protocol" letters and Product Accountability Forms were sent to consignees via Fed Ex on August 31, 2009 and September 1, 2009 with return receipt. Notification letters described the issue, protocols affected, potential hazard and harm and risk mitigation. Direct questions about the recall by calling 1-201-972-2100 or Customer Service 1 -866-OR-ASSIST (1 -866-672-7747).
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