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  • Dispositivo 1211
  • Fabricante 31827
  • Evento 5885
  • Implante 4142
Retiro De Equipo (Recall) de Device Recall Persona, The Personalized Knee System
  • Tipo de evento
    Recall
  • ID del evento
    63690
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0553-2013
  • Fecha de inicio del evento
    2012-11-14
  • Fecha de publicación del evento
    2012-12-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114665
  • 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
    All lots of the persona cemented tibial drill, 5 degree cemented stemmed natural tibia implants, and associated tools including the tibial drill guide, broach, and sizing plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening.
  • Acción
    Zimmer sent distributors beginning the week of November 14, 2012, E-mail information requesting all equipment be collected in distributors office before shipment back to Zimmer and replacement. A telephone conference discussing the recall and amended surgical technique was held the week of November 14, 2012, and Urgent Recall notices were sent to Distributors describing the devices; risks; updated surgical technique with directions to hand deliver surgeon/risk manager letters to all affected surgeons and risk managers in hospitals receiving the product. The notices included directions to remove all affected product and ensure risk manager letter is provided. The letter stated a Zimmer Inc. employee will conduct onsite reconciliation and asked return of distribution Spreadsheet to CorporateQuality.Postmarket@zimmer.com within 24 hours of receiving notification. Product is to be returned with certificate of sterilization to Zimmer Product Service Department 1777 West Center St. Warsaw, IN 46580 or Zimmer International Logistics, Eschbach Germany for International Accounts. For questions regarding this recall call 574-372-4807.
Retiro De Equipo (Recall) de Device Recall Persona, The Personalized Knee System
  • Tipo de evento
    Recall
  • ID del evento
    63690
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0554-2013
  • Fecha de inicio del evento
    2012-11-14
  • Fecha de publicación del evento
    2012-12-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114666
  • 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
    All lots of the persona cemented tibial drill, 5 degree cemented stemmed natural tibia implants, and associated tools including the tibial drill guide, broach, and sizing plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening.
  • Acción
    Zimmer sent distributors beginning the week of November 14, 2012, E-mail information requesting all equipment be collected in distributors office before shipment back to Zimmer and replacement. A telephone conference discussing the recall and amended surgical technique was held the week of November 14, 2012, and Urgent Recall notices were sent to Distributors describing the devices; risks; updated surgical technique with directions to hand deliver surgeon/risk manager letters to all affected surgeons and risk managers in hospitals receiving the product. The notices included directions to remove all affected product and ensure risk manager letter is provided. The letter stated a Zimmer Inc. employee will conduct onsite reconciliation and asked return of distribution Spreadsheet to CorporateQuality.Postmarket@zimmer.com within 24 hours of receiving notification. Product is to be returned with certificate of sterilization to Zimmer Product Service Department 1777 West Center St. Warsaw, IN 46580 or Zimmer International Logistics, Eschbach Germany for International Accounts. For questions regarding this recall call 574-372-4807.
Retiro De Equipo (Recall) de Device Recall Stryker Orthobiologics Aliquot Beveled Needle, 4", Pa...
  • Tipo de evento
    Recall
  • ID del evento
    63204
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1391-2013
  • Fecha de inicio del evento
    2012-11-10
  • Fecha de publicación del evento
    2013-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115058
  • 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
    Injector, vertebroplasty (does not contain cement) - Product Code OAR
  • Causa
    There have been a few reported cases of the catheter breaking when removing the aliquot catheter from the needle during vertebroplasty procedures. this has been attributed to bending of the catheter during the retraction from the needle. it was determined to be use errors. the correction is limited to a revision of the directions for use.
  • Acción
    Stryker sent an Urgent Medical Device Correction letter dated November 10, 2012 to all affected customers. The letter identified the affected product, problem issue, potential hazards and actions to be taken. Customers were instructed to immediately review this notification and the attached IFU. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to 1-484-323-8803. For questions contact Stryker Orthobiologics.
Retiro De Equipo (Recall) de Device Recall PopLok Punch 3.5MM
  • Tipo de evento
    Recall
  • ID del evento
    63823
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0789-2013
  • Fecha de inicio del evento
    2012-11-15
  • Fecha de publicación del evento
    2013-02-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-05-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114837
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    Conmed linvatech recalled one lot of their poplok bone punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm.
  • Acción
    ConMed Linvatech issued a "URGENT MEDICAL DEVICE RECALL NOTIFICATION" to its customers on November 15, 2012 for a recall that was conducted at the end user/distributor level. All recall notifications were sent FedEx next day delivery or equivalent method to notify all direct consignees. The notifications identified the affected product along with reason for the recall health risk. All accounts were asked to immediately check their facility for the affected product, stop using any of the product with specified lot number, and to segregate the product. The letter also asked customers to return all affected product to ConMed Linvatec and respond using a Reply Form. If customers have any additional questions, they should contact the Customer Service department at 800-237-0169. For questions regarding this recall call 727-399-5205.
Retiro De Equipo (Recall) de Device Recall Stryker Orthobiologics Aliquot Catheter, 8", Part Num...
  • Tipo de evento
    Recall
  • ID del evento
    63204
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1392-2013
  • Fecha de inicio del evento
    2012-11-10
  • Fecha de publicación del evento
    2013-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115059
  • 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
    Injector, vertebroplasty (does not contain cement) - Product Code OAR
  • Causa
    There have been a few reported cases of the catheter breaking when removing the aliquot catheter from the needle during vertebroplasty procedures. this has been attributed to bending of the catheter during the retraction from the needle. it was determined to be use errors. the correction is limited to a revision of the directions for use.
  • Acción
    Stryker sent an Urgent Medical Device Correction letter dated November 10, 2012 to all affected customers. The letter identified the affected product, problem issue, potential hazards and actions to be taken. Customers were instructed to immediately review this notification and the attached IFU. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to 1-484-323-8803. For questions contact Stryker Orthobiologics.
Retiro De Equipo (Recall) de Device Recall Stryker Orthobiologics Aliquot Plunger Delivery Syste...
  • Tipo de evento
    Recall
  • ID del evento
    63204
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1388-2013
  • Fecha de inicio del evento
    2012-11-10
  • Fecha de publicación del evento
    2013-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115050
  • 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
    Injector, vertebroplasty (does not contain cement) - Product Code OAR
  • Causa
    There have been a few reported cases of the catheter breaking when removing the aliquot catheter from the needle during vertebroplasty procedures. this has been attributed to bending of the catheter during the retraction from the needle. it was determined to be use errors. the correction is limited to a revision of the directions for use.
  • Acción
    Stryker sent an Urgent Medical Device Correction letter dated November 10, 2012 to all affected customers. The letter identified the affected product, problem issue, potential hazards and actions to be taken. Customers were instructed to immediately review this notification and the attached IFU. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to 1-484-323-8803. For questions contact Stryker Orthobiologics.
Retiro De Equipo (Recall) de Device Recall Stryker Orthobiologics Aliquot Plunger Delivery Syste...
  • Tipo de evento
    Recall
  • ID del evento
    63204
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1389-2013
  • Fecha de inicio del evento
    2012-11-10
  • Fecha de publicación del evento
    2013-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115051
  • 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
    Injector, vertebroplasty (does not contain cement) - Product Code OAR
  • Causa
    There have been a few reported cases of the catheter breaking when removing the aliquot catheter from the needle during vertebroplasty procedures. this has been attributed to bending of the catheter during the retraction from the needle. it was determined to be use errors. the correction is limited to a revision of the directions for use.
  • Acción
    Stryker sent an Urgent Medical Device Correction letter dated November 10, 2012 to all affected customers. The letter identified the affected product, problem issue, potential hazards and actions to be taken. Customers were instructed to immediately review this notification and the attached IFU. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to 1-484-323-8803. For questions contact Stryker Orthobiologics.
Retiro De Equipo (Recall) de Device Recall Stryker Orthobiologics Aliquot Syringe Delivery Syste...
  • Tipo de evento
    Recall
  • ID del evento
    63204
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1390-2013
  • Fecha de inicio del evento
    2012-11-10
  • Fecha de publicación del evento
    2013-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115052
  • 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
    Injector, vertebroplasty (does not contain cement) - Product Code OAR
  • Causa
    There have been a few reported cases of the catheter breaking when removing the aliquot catheter from the needle during vertebroplasty procedures. this has been attributed to bending of the catheter during the retraction from the needle. it was determined to be use errors. the correction is limited to a revision of the directions for use.
  • Acción
    Stryker sent an Urgent Medical Device Correction letter dated November 10, 2012 to all affected customers. The letter identified the affected product, problem issue, potential hazards and actions to be taken. Customers were instructed to immediately review this notification and the attached IFU. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to 1-484-323-8803. For questions contact Stryker Orthobiologics.
Retiro De Equipo (Recall) de Device Recall Stryker Orthobiologics Aliquot Catheter, 6", Part Num...
  • Tipo de evento
    Recall
  • ID del evento
    63204
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1399-2013
  • Fecha de inicio del evento
    2012-11-10
  • Fecha de publicación del evento
    2013-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115083
  • 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
    Injector, vertebroplasty (does not contain cement) - Product Code OAR
  • Causa
    There have been a few reported cases of the catheter breaking when removing the aliquot catheter from the needle during vertebroplasty procedures. this has been attributed to bending of the catheter during the retraction from the needle. it was determined to be use errors. the correction is limited to a revision of the directions for use.
  • Acción
    Stryker sent an Urgent Medical Device Correction letter dated November 10, 2012 to all affected customers. The letter identified the affected product, problem issue, potential hazards and actions to be taken. Customers were instructed to immediately review this notification and the attached IFU. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to 1-484-323-8803. For questions contact Stryker Orthobiologics.
Retiro De Equipo (Recall) de Device Recall Arthrotek Interference Screw
  • Tipo de evento
    Recall
  • ID del evento
    64004
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0753-2013
  • Fecha de inicio del evento
    2013-01-03
  • Fecha de publicación del evento
    2013-01-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115199
  • 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
    Thru hole at the tip of the screw is undersized.
  • Acción
    Biomet sent an URGENT MEDICAL DEVICE RECALL letter dated January 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed locate and discontinue use of the affected product and return it to Biomet. recall notification was sent to all consignees on 1/4/2013. The action requires the immediate location and discontinued use of the product and its return to Biomet. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8a.m. to 5 p.m. For questions regarding this recall call 574-267-6639, ext 1676.
Retiro De Equipo (Recall) de Device Recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS
  • Tipo de evento
    Recall
  • ID del evento
    65800
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2075-2013
  • Fecha de inicio del evento
    2013-07-16
  • Fecha de publicación del evento
    2013-08-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120214
  • 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
    Template - Product Code HWT
  • Causa
    The trial stems were manufactured using the wrong design.
  • Acción
    The firm notified their consignees of their product recall by parcel post on 07/16/2013.
Retiro De Equipo (Recall) de Device Recall NOVATION CROWN CUP 5mm LATERALIZED LINER
  • Tipo de evento
    Recall
  • ID del evento
    64028
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0788-2013
  • Fecha de inicio del evento
    2012-11-05
  • Fecha de publicación del evento
    2013-02-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115319
  • 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
    Recall of novation crown cup connection gxl neutral liners catalog no. (130-32-53) and novation crown cup connection gxl + 5mm lateralized liners catalog no. (136-32-53). exactech discovered the device labeling was inadvertently transposed.
  • Acción
    Exactech, Inc. notified consignees by telephone on 11/05/12 of the affected devices and sent an "IMPORTANT PRODUCT RECALL NOTICE" letter dated 11/06/12. The letter describes the purpose of the recall, the product affected, the problem and actions to be taken by the consignees. A Product Recall Response Form was attached for the consignees to contact the Exactech inventory representative within 5 business days to confirm quantities of product in their inventory and return them to Exactech. Consignees with any questions relating to these devices should call 1-800-392-2832.
Retiro De Equipo (Recall) de Device Recall 45 Angle Driver
  • Tipo de evento
    Recall
  • ID del evento
    64129
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0751-2013
  • Fecha de inicio del evento
    2013-01-16
  • Fecha de publicación del evento
    2013-01-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115397
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    Greatbatch medical has initiated a global voluntary recall and market withdrawal of its entire small angled driver 45¿ product line. greatbatch has received reports of noisy and / or rough operation when using these small angled drivers.
  • Acción
    Greatbatch sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 15, 2012 to all affected customers. The letter described the Reason For Recall, Risk to Health, and Instructions to Customers. Advised consignees to examine their inventory and quarantine the product in question. If they have further distributed the product to notify their customers and to complete and return the "Recall Response Form". Contact the firm at 1-763-951-8235 for questions relating to this notice.
Retiro De Equipo (Recall) de Device Recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS
  • Tipo de evento
    Recall
  • ID del evento
    65800
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2076-2013
  • Fecha de inicio del evento
    2013-07-16
  • Fecha de publicación del evento
    2013-08-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120215
  • 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
    Template - Product Code HWT
  • Causa
    The trial stems were manufactured using the wrong design.
  • Acción
    The firm notified their consignees of their product recall by parcel post on 07/16/2013.
Retiro De Equipo (Recall) de Device Recall Quadra Trial Broach size 0
  • Tipo de evento
    Recall
  • ID del evento
    64160
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0791-2013
  • Fecha de inicio del evento
    2012-12-17
  • Fecha de publicación del evento
    2013-02-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115467
  • 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
    Quadra Trial Broach size 0 - Product Code MEH
  • Causa
    The tip of the quadra trial broach size 0, broke during a surgery.
  • Acción
    Medacta sent a Urgent Safety Notification letter dated December 13, 2012 to all affected customers. The letter identified the recalled product, problem and actions to be taken. Customers were instructed to check inventory for affected product and contact QA@medacta.us.com for an RMA# to return items to Medacta USA. A new version of the recalled product will be provided to all affected customers. For questions call 805-437-7085 x26.
Retiro De Equipo (Recall) de Device Recall Synthes Flexible Grip
  • Tipo de evento
    Recall
  • ID del evento
    64200
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1062-2013
  • Fecha de inicio del evento
    2013-01-11
  • Fecha de publicación del evento
    2013-04-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115546
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    Synthes is initiating a voluntary recall of the flexible grip (part number 355.28) which is part of the universal nail system, due to the potential lack of the ability to thoroughly clean the instrument.
  • Acción
    Synthes sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" dated January 11, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter requested consignees examine inventory, remove the recalled products from use and return them to Synthes. If you have any questions, contact the firm at 610-719-5450.
Retiro De Equipo (Recall) de Device Recall Synthes Oracle Spacer System Slap Hammer, Part Number...
  • Tipo de evento
    Recall
  • ID del evento
    64236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2282-2013
  • Fecha de inicio del evento
    2013-01-11
  • Fecha de publicación del evento
    2013-09-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115645
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    This recall is being initiated in response to complaints received where it was reported that the proximal end of the slap hammer broke during use.
  • Acción
    SYNTHES sent an Urgent Notice Medical Device Recall letter dated January 11, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested consignees examine their inventory, remove the recalled product from use and return them to Synthes. Customers were also instructed to completed the attached Verification Section at the end of the letter indicating whether or not they had any of the affected product and the number of devices found. Customers with questions were instructed to call 610-719-5450 or email Fieldaction@synthes.com. For questions regarding this recall call 610-719-5000.
Retiro De Equipo (Recall) de Device Recall Anspach Knotless Suture Anchor Deployment Tool, Custom
  • Tipo de evento
    Recall
  • ID del evento
    64247
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1875-2014
  • Fecha de inicio del evento
    2012-11-28
  • Fecha de publicación del evento
    2014-06-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115666
  • 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 anspach effort, inc. in palm beach gardens, fl is recalling the anspach custom devices. the units and the records of these products were not consistent with quality system requirements.
  • Acción
    The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887. For questions regarding this recall call 561-494-3706.
Retiro De Equipo (Recall) de Device Recall ReClaim Reamer Extension
  • Tipo de evento
    Recall
  • ID del evento
    64285
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0972-2013
  • Fecha de inicio del evento
    2013-02-25
  • Fecha de publicación del evento
    2013-03-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115761
  • 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
    Reamer - Product Code HTO
  • Causa
    The tabs on the reamer extension device have broken. depuy is notifying surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient. once the root cause is determined and a design change is implemented, depuy will conduct a formal swap-out of the affected devices.
  • Acción
    DePuy Synthes sent a Urgent Information Medical Device Correction Notice to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed upon visual inspection, if the reamer extension is found to have one or more tabs broken, please do not use the reamer extension. The reamer extension will still engage with one tab intact and no clinical implications have been identified with the use of the reamer extension with one tab, but DePuy recommends it be returned and the alternate reamer extension device be used. If both tabs are broken, the reamer extension will not engage and DePuy recommends it be returned and the alternate reamer extension device be used. A reamer extractor is available in the instrument kit for removal of the reamer if necessary. In order to reduce the risk of breaking the tabs during surgery, the Reamer Extension should only be used to drive the Distal Reamer axially within the patients femoral canal. The instrument is NOT intended to be used for side-cutting or lateralizing the femoral canal, therefore, no off-axis force should be applied during distal reaming. The purpose of this communication is to inform you of this device correction and request acknowledgement of receipt of this letter by signing and returning the Surgeon Response Card within 14 days of receiving this notice. Response cards should be faxed to Fax Number: 574-371-4939. For product-related questions, please contact your local DePuy Orthopaedics Sales Representative. For clinical-related questions from surgeons, please have them contact DePuys Scientific Information Office at 1-888-554-2482 (M-F; 8 am to 5 pm EST.) For questions about device correction information provided, 574-372-7333 (M-F: 8 am to 5 pm EST.)
Retiro De Equipo (Recall) de Device Recall Versafitcup Total Hip SystemImpacting Ring
  • Tipo de evento
    Recall
  • ID del evento
    64294
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0878-2013
  • Fecha de inicio del evento
    2010-01-15
  • Fecha de publicación del evento
    2013-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115770
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
  • Causa
    Medacta usa is recalling versafitcup impacting ring because the impaction ring may not fit properly in the implant shell in all cases. this could result in surgical delay potentially increasing possible complications under anesthesia, having to ream up to a larger shell size leaving less bone than planned and repositiong/removal of the shell after initial impaction.
  • Acción
    Medacta USA sent notification letters dated 1/15/10 to Sales Representatives for customers that purchased the Versafitcup Impacting Ring. The letter informed the customers of the problem identified and the actions to be taken. Customers are informed that Medacta USA personnel will contact them by telephone to provide them with a RMA number. Customers are informed that they will receive a new set of redesigned/reworked impacting rings and a second near the end of the January 2010. Customers with questions are instructed to contact the firm at (805) 437-7085.
Retiro De Equipo (Recall) de Device Recall Stryker Howmedica Osteonics Corp.
  • Tipo de evento
    Recall
  • ID del evento
    64306
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0919-2013
  • Fecha de inicio del evento
    2012-12-20
  • Fecha de publicación del evento
    2013-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115789
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.
  • Acción
    Stryker Orthopaedics sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" dated December 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (201) 972-2100 for questions regarding this issue.
Retiro De Equipo (Recall) de Device Recall ShapeMatch Cutting Guides
  • Tipo de evento
    Recall
  • ID del evento
    64308
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1052-2013
  • Fecha de inicio del evento
    2012-11-08
  • Fecha de publicación del evento
    2013-04-12
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115791
  • 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, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • Causa
    With regards to shapematch cutting guides using mri imaging, stryker orthopaedics has become aware that there are potential issues associated with internal processes for planning cases and producing shapematch cutting guides.
  • Acción
    Stryker sent Product Correction Bulletins on 11/8/2012 dated 11/9/2012 and 11/19/2012 to all affected customers. Stryker sent an updated Urgent Medical Device Product Notification letters and Acknowledgement letters dated 1/24/2013 through 1/28/2013 to all affected customers via Fed Ex with return receipt: The letter identified the affect product, problem, potential hazards, risk mitigating factors and actions to be taken. For questions call 201-831-6878. Stryker issued press release on 4/10/2013.
Retiro De Equipo (Recall) de Device Recall Extremity Medical Disposable Instrument 1.6 mm Guide...
  • Tipo de evento
    Recall
  • ID del evento
    64330
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0952-2013
  • Fecha de inicio del evento
    2013-01-10
  • Fecha de publicación del evento
    2013-03-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115841
  • 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
    Passer, wire, orthopedic - Product Code HXI
  • Causa
    The 1.6 mm guidewire is undersized up to 2 mm in length. when used with the depth gauge, the measurement reading will not correspond with the desired screw length. the selected screw size based on the depth gauge reading will be about 2 mm longer than intended.
  • Acción
    Extremity Medical sent an "URGENT: FIELD SAFETY NOTICE" dated January 10, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Response Form was included for customers to complete and return. Contact Customer Service at 1 (973) 588-8980 for questions regarding this notice. On April 10, 2013, Extremity sent notifications to their customers at the surgeon level. They were asked to complete the attached product field action response form.
Retiro De Equipo (Recall) de Device Recall Anspach Arthroscopic Suture Anchor Assembly with Sutu...
  • Tipo de evento
    Recall
  • ID del evento
    64247
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1914-2014
  • Fecha de inicio del evento
    2012-11-28
  • Fecha de publicación del evento
    2014-06-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115913
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Arthroscope - Product Code HRX
  • Causa
    The anspach effort, inc. in palm beach gardens, fl is recalling their anspach custom devices. the units were not manufactured consistently with quality system requirements.
  • Acción
    The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887. For questions regarding this recall call 561-494-3706.
Retiro De Equipo (Recall) de Device Recall Biomet Spine Polaris 5.5 Button Lock Screw Inserter.
  • Tipo de evento
    Recall
  • ID del evento
    64452
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0954-2013
  • Fecha de inicio del evento
    2013-02-07
  • Fecha de publicación del evento
    2013-03-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116169
  • 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
    Screwdriver - Product Code HXX
  • Causa
    Increased risk of failure at the driver tip during screw insertion or removal.
  • Acción
    Biomet Spine sent a "Urgent Medical Device Recall" notices dated February 6, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately locate and remove affected items from circulation and return affected product to EBI, LLC. Please follow the instructions on the enclosed "FAX Back Response Form, " and fax a copy of the Response Form to (973) 257-0232, prior to return of the items. Questions related to this notice should be directed to (973) 299-9300 ex. 2322. Monday through Friday, 8am to 5pm.
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