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
Implant, endosseous, root-form - Product Code DZE
Causa
This zimmer dental voluntary device recall resulted from an investigation into the february 2012 complaint involving an apical tip of a 4.1mm d trabecular metal implant which separated from the implant assembly during surgery on a patient with a dense (type d1), thick, inferior border. the recall correction includes adding precautions to the instructions for use regarding the placement of a 4.1mm.
Acción
Zimmer sent an Urgent Medical Device Correction notification letter dated April 24, 2012, with an attached Technical Bulletin listing precautions present in the new Informaiton for Use sent to distributors and customers via E-mail and FED EX. Notifications identified the issue and risks found with the device listing responsibilties, precautions, and procedural precautions. Notifications contained directions to forward information to any sub accounts and clinicians. Zimmer had telephone follow-up with each distributor and customer to assure information was received and is understood. Questions should be directed to Technical Service (800)8511-7019 orCustomer Service(760) 929-1300 or Regulatory Affairs at 1-800-854-7019 .
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.
Notas adicionales en la data
System, nuclear magnetic resonance imaging - Product Code LNH
Causa
During product monitoring, siemens has discovered that the gradient cable connections on a few systems did not meet their specifications after installation. the cable connections overheated, leading to the emission of smoke and possible material damage.
Acción
The firm, Siemens Medical Solutions USA, Inc., sent a "Customer Safety Advisory Notice" including Update Instruction MR028/10/S dated March 2012 to affected customers via hand delivery by Siemens Service Engineer . The notice described the product, problem and actions to be taken. The customers were instructed to create a COBR image and to make a copy of the attached "Completion Protocol" fill it out and file in their corresponding binder.
Siemens Service Engineer performed an all gradient cable connection visual inspection as well as torque check on the connecting screws at the sites and the factory prior to their release to the field. Siemens also issued a current Update Instruction MR024/11/S.
If you have any questions regarding this report, please contact the Quality Engineer, Product Complaints & Field Support at 610-219-4834; email: anastasia.mason@siemens.com or Director, Product Complaints & Field Support at 610-448-4634 or email: josephine.mcbride@siemens.com.
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.
Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, 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 Cuba.
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.
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
Exactech inc. of gainesville, fl is recalling their novation modular drill bits after the devices were reported to have been used by end user while in a non-sterile condition.
Acción
The firm, Exactech, Inc., called the lone customer on January 24, 2012 to discuss the product, problem and actions to be taken. The customer was instructed to return all unused devices and associated packaging.
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.
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.
Beginning in february 2011, stryker spine began receiving reports related to the shaft of the avs navigator trial failing at the junction of the trial head.
Acción
Stryker sent an "URGENT PRODUCT RECALL" letter to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Customer Response Form was included for customers to complete and return via fax to Regulatory Compliance at 201-760-8370. Contact the firm at 201-760-8298 for questions regarding this recall.
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.
Notas adicionales en la data
Pump, infusion - Product Code FRN
Causa
Ambulatory administration sets used with the curlin ambulatory pumps including the 4000 cms ambulatory pump, 6000 cms ambulatory pump and the pain smart iod ambulatory pump may leak during use.
Acción
Moog Medical Device Group sent a Medical Device Recall Notification letter dated March 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from their inventory, contact the distributor or Moog Customer Service at 1-800-970-2337, prompt #7, then return product to distributor or Moog.
For additional questions regarding this recall call Moog's Customer Service Department at (800) 970-2337.
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
Pump, infusion - Product Code FRN
Causa
Ambulatory administration sets used with the curlin ambulatory pumps including the 4000 cms ambulatory pump, 6000 cms ambulatory pump and the pain smart iod ambulatory pump may leak during use.
Acción
Moog Medical Device Group sent a Medical Device Recall Notification letter dated March 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from their inventory, contact the distributor or Moog Customer Service at 1-800-970-2337, prompt #7, then return product to distributor or Moog.
For additional questions regarding this recall call Moog's Customer Service Department at (800) 970-2337.
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
Pump, infusion - Product Code FRN
Causa
Ambulatory administration sets used with the curlin ambulatory pumps including the 4000 cms ambulatory pump, 6000 cms ambulatory pump and the pain smart iod ambulatory pump may leak during use.
Acción
Moog Medical Device Group sent a Medical Device Recall Notification letter dated March 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from their inventory, contact the distributor or Moog Customer Service at 1-800-970-2337, prompt #7, then return product to distributor or Moog.
For additional questions regarding this recall call Moog's Customer Service Department at (800) 970-2337.
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
Pump, infusion - Product Code FRN
Causa
Ambulatory administration sets used with the curlin ambulatory pumps including the 4000 cms ambulatory pump, 6000 cms ambulatory pump and the pain smart iod ambulatory pump may leak during use.
Acción
Moog Medical Device Group sent a Medical Device Recall Notification letter dated March 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from their inventory, contact the distributor or Moog Customer Service at 1-800-970-2337, prompt #7, then return product to distributor or Moog.
For additional questions regarding this recall call Moog's Customer Service Department at (800) 970-2337.
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
Pump, infusion - Product Code FRN
Causa
Ambulatory administration sets used with the curlin ambulatory pumps including the 4000 cms ambulatory pump, 6000 cms ambulatory pump and the pain smart iod ambulatory pump may leak during use.
Acción
Moog Medical Device Group sent a Medical Device Recall Notification letter dated March 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from their inventory, contact the distributor or Moog Customer Service at 1-800-970-2337, prompt #7, then return product to distributor or Moog.
For additional questions regarding this recall call Moog's Customer Service Department at (800) 970-2337.
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
Pump, infusion - Product Code FRN
Causa
Ambulatory administration sets used with the curlin ambulatory pumps including the 4000 cms ambulatory pump, 6000 cms ambulatory pump and the pain smart iod ambulatory pump may leak during use.
Acción
Moog Medical Device Group sent a Medical Device Recall Notification letter dated March 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from their inventory, contact the distributor or Moog Customer Service at 1-800-970-2337, prompt #7, then return product to distributor or Moog.
For additional questions regarding this recall call Moog's Customer Service Department at (800) 970-2337.
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
Pump, infusion - Product Code FRN
Causa
Ambulatory administration sets used with the curlin ambulatory pumps including the 4000 cms ambulatory pump, 6000 cms ambulatory pump and the pain smart iod ambulatory pump may leak during use.
Acción
Moog Medical Device Group sent a Medical Device Recall Notification letter dated March 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from their inventory, contact the distributor or Moog Customer Service at 1-800-970-2337, prompt #7, then return product to distributor or Moog.
For additional questions regarding this recall call Moog's Customer Service Department at (800) 970-2337.
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
Pump, infusion - Product Code FRN
Causa
Ambulatory administration sets used with the curlin ambulatory pumps including the 4000 cms ambulatory pump, 6000 cms ambulatory pump and the pain smart iod ambulatory pump may leak during use.
Acción
Moog Medical Device Group sent a Medical Device Recall Notification letter dated March 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from their inventory, contact the distributor or Moog Customer Service at 1-800-970-2337, prompt #7, then return product to distributor or Moog.
For additional questions regarding this recall call Moog's Customer Service Department at (800) 970-2337.