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
Plate, fixation, bone - Product Code HRS
Causa
Zimmer inc., is initiating a correction to the patient labels of products manufactured before march 20i0 by the zimmer gmbh production site in winterthur, switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. while the information printed on the product label is correct, the info.
Acción
Zimmer, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265.
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
Plate, fixation, bone - Product Code HRS
Causa
Zimmer inc., is initiating a correction to the patient labels of products manufactured before march 20i0 by the zimmer gmbh production site in winterthur, switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. while the information printed on the product label is correct, the info.
Acción
Zimmer, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265.
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
Zimmer inc., is initiating a correction to the patient labels of products manufactured before march 20i0 by the zimmer gmbh production site in winterthur, switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. while the information printed on the product label is correct, the info.
Acción
Zimmer, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265.
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.
Zimmer inc., is initiating a correction to the patient labels of products manufactured before march 20i0 by the zimmer gmbh production site in winterthur, switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. while the information printed on the product label is correct, the info.
Acción
Zimmer, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265.
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.
Zimmer has received 5 complaints where a nexgen cr micro articular surface was used with a standard cr femur, even though the compatibility chart and product labeling indicates that these components are not compatible. investigation identified additional instances where a cr micro articular surface and standard cr femur were sold together on the same purchase order. cr micro articular surfaces are.
Acción
Zimmer sent an Urgent Correction Notice dated March 5, 2012, to all affected customers via telephone, E-mail and letter notifying users of the appropriate compatibility of micro sizes of NexGen¿ CR and CR-Flex Articular Surfaces and informing them of known cases of incompatible devices being implanted, including associated risks. Customers and surgeons were asked to acknowledge receipt by calling 1-888-912-7349. Questions and concerns or help in notiying accounts about this correction were to be addressed to 1-888-548-8514.
For questions regarding this recall call 574-372-4807.
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.
Zimmer inc., is initiating a correction to the patient labels of products manufactured before march 20i0 by the zimmer gmbh production site in winterthur, switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. while the information printed on the product label is correct, the info.
Acción
Zimmer, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265.
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.
Zimmer has received 5 complaints where a nexgen cr micro articular surface was used with a standard cr femur, even though the compatibility chart and product labeling indicates that these components are not compatible. investigation identified additional instances where a cr micro articular surface and standard cr femur were sold together on the same purchase order. cr micro articular surfaces are.
Acción
Zimmer sent an Urgent Correction Notice dated March 5, 2012, to all affected customers via telephone, E-mail and letter notifying users of the appropriate compatibility of micro sizes of NexGen¿ CR and CR-Flex Articular Surfaces and informing them of known cases of incompatible devices being implanted, including associated risks. Customers and surgeons were asked to acknowledge receipt by calling 1-888-912-7349. Questions and concerns or help in notiying accounts about this correction were to be addressed to 1-888-548-8514.
For questions regarding this recall call 574-372-4807.
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.
Zimmer has received 5 complaints where a nexgen cr micro articular surface was used with a standard cr femur, even though the compatibility chart and product labeling indicates that these components are not compatible. investigation identified additional instances where a cr micro articular surface and standard cr femur were sold together on the same purchase order. cr micro articular surfaces are.
Acción
Zimmer sent an Urgent Correction Notice dated March 5, 2012, to all affected customers via telephone, E-mail and letter notifying users of the appropriate compatibility of micro sizes of NexGen¿ CR and CR-Flex Articular Surfaces and informing them of known cases of incompatible devices being implanted, including associated risks. Customers and surgeons were asked to acknowledge receipt by calling 1-888-912-7349. Questions and concerns or help in notiying accounts about this correction were to be addressed to 1-888-548-8514.
For questions regarding this recall call 574-372-4807.
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.
Zimmer has received 5 complaints where a nexgen cr micro articular surface was used with a standard cr femur, even though the compatibility chart and product labeling indicates that these components are not compatible. investigation identified additional instances where a cr micro articular surface and standard cr femur were sold together on the same purchase order. cr micro articular surfaces are.
Acción
Zimmer sent an Urgent Correction Notice dated March 5, 2012, to all affected customers via telephone, E-mail and letter notifying users of the appropriate compatibility of micro sizes of NexGen¿ CR and CR-Flex Articular Surfaces and informing them of known cases of incompatible devices being implanted, including associated risks. Customers and surgeons were asked to acknowledge receipt by calling 1-888-912-7349. Questions and concerns or help in notiying accounts about this correction were to be addressed to 1-888-548-8514.
For questions regarding this recall call 574-372-4807.
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.
Zimmer has received 5 complaints where a nexgen cr micro articular surface was used with a standard cr femur, even though the compatibility chart and product labeling indicates that these components are not compatible. investigation identified additional instances where a cr micro articular surface and standard cr femur were sold together on the same purchase order. cr micro articular surfaces are.
Acción
Zimmer sent an Urgent Correction Notice dated March 5, 2012, to all affected customers via telephone, E-mail and letter notifying users of the appropriate compatibility of micro sizes of NexGen¿ CR and CR-Flex Articular Surfaces and informing them of known cases of incompatible devices being implanted, including associated risks. Customers and surgeons were asked to acknowledge receipt by calling 1-888-912-7349. Questions and concerns or help in notiying accounts about this correction were to be addressed to 1-888-548-8514.
For questions regarding this recall call 574-372-4807.