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.
The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. conmed evaluated the potential risk that this issue could present to the patient and concluded the risk of injury to be negligible; however exposure could cause a minor, local, self correcting infection.
Acción
The firm, ConMed, sent an "URGENT: VOLUNTARY DEVICE RECALL" letter dated October 23, 2013 and Business Reply Forms to the domestic consignees/customers via USPS Priority Mail. Distribution of the recall letter to the foreign consignees will follow once the letter has been translated into the different foreign languages. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately stop the use of these devices; review your inventory for any of the devices listed; contact all of those organizations within your facility and any other facilities that you may have supplied or given these affected products to; complete and return the ATTACHMENT I Effectiveness Check Business Reply Form via fax to: ConMed Recall Coordinator at 315-624-3225.
If you have any of the affected devices, please complete Attachment I and return it with the devices to: ConMed Corporation, 525 French Road, Utica, NY 13502
Attn. Ed Kovac, Return via: FedEx Account # 487553646. Please indicate with your returned devices, if you are requesting credit or replacement of the devices. Please do not return used devices.
If you do not have any devices to return, please complete Attachment I, indicating you have no devices and fax it to 315-624-3225, Attn: ConMed Recall Coordinator.
For questions, please contact ConMed Recall Coordinator at 315-624-3237 or e-mail altrus@conmed.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.
The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. conmed evaluated the potential risk that this issue could present to the patient and concluded the risk of injury to be negligible; however exposure could cause a minor, local, self correcting infection.
Acción
The firm, ConMed, sent an "URGENT: VOLUNTARY DEVICE RECALL" letter dated October 23, 2013 and Business Reply Forms to the domestic consignees/customers via USPS Priority Mail. Distribution of the recall letter to the foreign consignees will follow once the letter has been translated into the different foreign languages. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately stop the use of these devices; review your inventory for any of the devices listed; contact all of those organizations within your facility and any other facilities that you may have supplied or given these affected products to; complete and return the ATTACHMENT I Effectiveness Check Business Reply Form via fax to: ConMed Recall Coordinator at 315-624-3225.
If you have any of the affected devices, please complete Attachment I and return it with the devices to: ConMed Corporation, 525 French Road, Utica, NY 13502
Attn. Ed Kovac, Return via: FedEx Account # 487553646. Please indicate with your returned devices, if you are requesting credit or replacement of the devices. Please do not return used devices.
If you do not have any devices to return, please complete Attachment I, indicating you have no devices and fax it to 315-624-3225, Attn: ConMed Recall Coordinator.
For questions, please contact ConMed Recall Coordinator at 315-624-3237 or e-mail altrus@conmed.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.
Ge healthcare has recently become aware of a potential safety issue due to the image orientation within gsi viewer on aw products.
the gsi viewer application running on aw/volume share or on the aw server when making a batch and rotating the batch group clockwise 180 degrees (inferior to superior) will display images in the superior orientation. the orientation annotation on the image is correc.
Acción
The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated September 19, 2013 to its consignees/customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (800-437-1171 for USA and Canada or contact local GE Healthcare Applications Specialist). The customers were instructed to "Please ensure that all potential users in your facility are made aware of this safety notification and the action taken". GE Healthcare will provide a software update for all affected systems to address the issue. A GE Healthcare service representative will contact you to arrange for this correction. This activity will be performed at no cost to you.
A second updated letter was sent on October 22, 2013 to correct the Affected Product Details communicated in the previous letter dated September 19, 2013. The new statement reads "All versions of GSI Viewer prior to version 2.00-OM on AW and prior to version 2.20- OB on AW Server are affected".
If you have any questions, please contact us at 800-437-1171 (USA and Canada) or contact local GE Healthcare Applications Specialist.
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.
One material batch used for production of the affected parts of the synthes material mix were mixed in with an incorrect material with a lower than specified hardness and corrosion resistance.
Acción
SYNTHES sent an Urgent Notice: Medical Device Recall letter dated October 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product was located. Customers were also asked to indicate the number of devices found and note the Return Authorization Number. Return the Verification Form with the product to:
Credit/Returns
Synthes
1101 Synthes Avenue
Monument, CO 80132
Customers should also return the Verification Form if no affected product was found in their inventory.
Return all documents to Synthes by fax: 888-679-4875 or Scan/email: FieldAction@synthes.com
Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant.
For questions regarding this recall call 610-719-5000.
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
A potential exists for non conforming synthes titanium trochanteric fixation nail (tfn)-helical blades to be distributed.
Acción
Synthes sent a Field Safety Notice dated October 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 to review the options provided in the Field Safety Notice to clarify and mitigate the potential risk. Customers were asked to prepare a list of the affected part and lot numbers and contact the Complaint Unit at 610-719-5596 to receive a Return Authorization Number. Complete and return the Verification Form with the product and Return Authorization number. Customers were also asked to forward the Field Safety Notice to anyone in their facility that needs to be informed. Customers were asked to maintain a copy of the Field Safety Notice.
Customers with questions were asked to call 610-719-5450 or contact their Synthes Sales Consultant.
For questions regarding this recall call 610-719-5000.
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
Computer assisted hair harvesting system - Product Code ONA
Causa
Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. discoloration due to insufficient cleaning of stainless steel pins during passivation process. the residue has
been identified as a compound of iron and chlorine.
Acción
Restoration Robotics sent an Urgent Recall letters dated October 13, 2013 to all distributors via first class mail. Direct accounts were notified by phone as well as fax. Customers were informed of the affected product, problem and actions to be taken. Replacement products are being distributed to each site and will be delivered to each customer. For questions call 408-883-6760
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
Computer assisted hair harvesting system - Product Code ONA
Causa
Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. discoloration due to insufficient cleaning of stainless steel pins during passivation process. the residue has
been identified as a compound of iron and chlorine.
Acción
Restoration Robotics sent an Urgent Recall letters dated October 13, 2013 to all distributors via first class mail. Direct accounts were notified by phone as well as fax. Customers were informed of the affected product, problem and actions to be taken. Replacement products are being distributed to each site and will be delivered to each customer. For questions call 408-883-6760
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
Computer assisted hair harvesting system - Product Code ONA
Causa
Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. discoloration due to insufficient cleaning of stainless steel pins during passivation process. the residue has
been identified as a compound of iron and chlorine.
Acción
Restoration Robotics sent an Urgent Recall letters dated October 13, 2013 to all distributors via first class mail. Direct accounts were notified by phone as well as fax. Customers were informed of the affected product, problem and actions to be taken. Replacement products are being distributed to each site and will be delivered to each customer. For questions call 408-883-6760
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
Computer assisted hair harvesting system - Product Code ONA
Causa
Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. discoloration due to insufficient cleaning of stainless steel pins during passivation process. the residue has
been identified as a compound of iron and chlorine.
Acción
Restoration Robotics sent an Urgent Recall letters dated October 13, 2013 to all distributors via first class mail. Direct accounts were notified by phone as well as fax. Customers were informed of the affected product, problem and actions to be taken. Replacement products are being distributed to each site and will be delivered to each customer. For questions call 408-883-6760
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.
Philips healthcare became aware of a software problem with the intellispace pacs system, in that a timing issue has been identified that may result in a condition where the device does not store additional images received before processing is complete. the missing images may contain pathology which may result in a different diagnosis if they had been available at time of interpretation.
Acción
Philips sent an Urgent Field Safety Notice dated October 14, 2013, to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Please review the following with all radiology technicians who use lntelliSpace
BY CUSTOMER/USER PACS:
" Assure you and your colleagues are aware of the problem.
" Verify that all images sent for each study are present on the iVault
before the images are purged from the modality.
o Use the image count from the lower right corner of the
thumbnails as seen in Enterprise only. Single images (such as
CR, DX and MG) show no image count, so the user should
count those thumbnails without image counts as one. Add all the
numbers up to come up with the total number of viewable
images, stored to lntelliSpace.
" Compare number of images sent from the modality and those sent from
other 3rd party source to image count in IntelliSpace PACS.
" If the image count on the modality or 3 party source indicates there are
more images to the study than are present on the iVault, the study
should be resent from the modality and/or 3 party source.
" Resending the studies will typically correct the problem but the
technician should again verify the image count is correct.
If you need any further information or support concerning this issue, please
INFORMATION AND contact your Philips representative or contact Care at isitecare@philips.com. Please call (650) 293-2300 for further questions.
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
Clip, aneurysm - Product Code HCH
Causa
Specific item numbers form lots 27-j and 29-j of sugita t2 aneurysm clips. mini temporary type, are discolored.
Acción
Mizuho sent a Product Recall Notice dated October 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to verify serial number before opening package and conduct a physical examination of the product for discolored Clips from the affected lots. Customers were also asked to fill out the Confirmation of User Receipt, and return to Misuho America. If customers should find affed clips they were instructed to quarantine them an call Mizuho America Customer Service at 800-699-2547 for return instructions. The Clips will be exchanged at no charge. Customers were also asked to ensure that all appropriate persons within the Hospital have been notified of the Recall Notice.
For questions regarding this recall call 510-324-4500, ext 122.
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
Clip, aneurysm - Product Code HCH
Causa
Specific item numbers form lots 27-j and 29-j of sugita t2 aneurysm clips. mini temporary type, are discolored.
Acción
Mizuho sent a Product Recall Notice dated October 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to verify serial number before opening package and conduct a physical examination of the product for discolored Clips from the affected lots. Customers were also asked to fill out the Confirmation of User Receipt, and return to Misuho America. If customers should find affed clips they were instructed to quarantine them an call Mizuho America Customer Service at 800-699-2547 for return instructions. The Clips will be exchanged at no charge. Customers were also asked to ensure that all appropriate persons within the Hospital have been notified of the Recall Notice.
For questions regarding this recall call 510-324-4500, ext 122.
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
Wire, guide, catheter - Product Code DQX
Causa
Potential for ptfe (polytetrafluroethylene) coating to delaminate and detach from guidewire.
Acción
The firm, Medtronic, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 21, 2013 (in the US via UPS overnight service, 1-day delivery) to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove and quarantine all potentially affected guidewires that remain in inventory; return the affected product to Medtronic; if replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product, and to complete and return the Customer Confirmation Certificate confirming receipt of the notification via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality (100% customer confirmations will be required).
Should have any questions, please contact your Medtronic Representative or call 763-526-2513.
Notifications to customers concerning the additional affected product began December 19, 2013 (in the US via UPS overnight service, 1-day delivery). Customers are requested to return a Confirmation Certificate confirming
their receipt of the notification. 100% customer confirmations will be required from the additional consignees.
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
Occluder, catheter tip - Product Code DQT
Causa
Potential for ptfe (polytetrafluroethylene) coating to delaminate and detach from guidewire.
Acción
The firm, Medtronic, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 21, 2013 (in the US via UPS overnight service, 1-day delivery) to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove and quarantine all potentially affected guidewires that remain in inventory; return the affected product to Medtronic; if replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product, and to complete and return the Customer Confirmation Certificate confirming receipt of the notification via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality (100% customer confirmations will be required).
Should have any questions, please contact your Medtronic Representative or call 763-526-2513.
Notifications to customers concerning the additional affected product began December 19, 2013 (in the US via UPS overnight service, 1-day delivery). Customers are requested to return a Confirmation Certificate confirming
their receipt of the notification. 100% customer confirmations will be required from the additional consignees.
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 And Syringe, Angiographic - Product Code DXT
Causa
Sterility can be compromised by a component tearing the outer packaging.
Acción
The recalling firm telephoned their customers on 10/8/04 to inform them of the problem and the need to return the product.
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.
Potential for ptfe (polytetrafluroethylene) coating to delaminate and detach from guidewire.
Acción
The firm, Medtronic, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 21, 2013 (in the US via UPS overnight service, 1-day delivery) to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove and quarantine all potentially affected guidewires that remain in inventory; return the affected product to Medtronic; if replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product, and to complete and return the Customer Confirmation Certificate confirming receipt of the notification via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality (100% customer confirmations will be required).
Should have any questions, please contact your Medtronic Representative or call 763-526-2513.
Notifications to customers concerning the additional affected product began December 19, 2013 (in the US via UPS overnight service, 1-day delivery). Customers are requested to return a Confirmation Certificate confirming
their receipt of the notification. 100% customer confirmations will be required from the additional consignees.
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
Wire, guide, catheter - Product Code DQX
Causa
Potential for ptfe (polytetrafluroethylene) coating to delaminate and detach from guidewire. medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in
the coronary and peripheral vasculature, and may be used to reach and cross a
target lesion. medtronic guide wires are not intended for cerebral vasculature.
medt.
Acción
The firm, Medtronic, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 21, 2013 (in the US via UPS overnight service, 1-day delivery) to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove and quarantine all potentially affected guidewires that remain in inventory; return the affected product to Medtronic; if replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product, and to complete and return the Customer Confirmation Certificate confirming receipt of the notification via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality (100% customer confirmations will be required).
Should have any questions, please contact your Medtronic Representative or call 763-526-2513.
Notifications to customers concerning the additional affected product began December 19, 2013 (in the US via UPS overnight service, 1-day delivery). Customers are requested to return a Confirmation Certificate confirming
their receipt of the notification. 100% customer confirmations will be required from the additional consignees.
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
Wire, guide, catheter - Product Code DQX
Causa
Potential for ptfe (polytetrafluroethylene) coating to delaminate and detach from guidewire.
Acción
The firm, Medtronic, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 21, 2013 (in the US via UPS overnight service, 1-day delivery) to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove and quarantine all potentially affected guidewires that remain in inventory; return the affected product to Medtronic; if replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product, and to complete and return the Customer Confirmation Certificate confirming receipt of the notification via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality (100% customer confirmations will be required).
Should have any questions, please contact your Medtronic Representative or call 763-526-2513.
Notifications to customers concerning the additional affected product began December 19, 2013 (in the US via UPS overnight service, 1-day delivery). Customers are requested to return a Confirmation Certificate confirming
their receipt of the notification. 100% customer confirmations will be required from the additional consignees.
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
Wire, guide, catheter - Product Code DQX
Causa
Potential for ptfe (polytetrafluroethylene) coating to delaminate and detach from guidewire.
Acción
The firm, Medtronic, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 21, 2013 (in the US via UPS overnight service, 1-day delivery) to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove and quarantine all potentially affected guidewires that remain in inventory; return the affected product to Medtronic; if replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product, and to complete and return the Customer Confirmation Certificate confirming receipt of the notification via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality (100% customer confirmations will be required).
Should have any questions, please contact your Medtronic Representative or call 763-526-2513.
Notifications to customers concerning the additional affected product began December 19, 2013 (in the US via UPS overnight service, 1-day delivery). Customers are requested to return a Confirmation Certificate confirming
their receipt of the notification. 100% customer confirmations will be required from the additional consignees.
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.
Potential for ptfe (polytetrafluroethylene) coating to delaminate and detach from guidewire.
Acción
The firm, Medtronic, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 21, 2013 (in the US via UPS overnight service, 1-day delivery) to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove and quarantine all potentially affected guidewires that remain in inventory; return the affected product to Medtronic; if replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product, and to complete and return the Customer Confirmation Certificate confirming receipt of the notification via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality (100% customer confirmations will be required).
Should have any questions, please contact your Medtronic Representative or call 763-526-2513.
Notifications to customers concerning the additional affected product began December 19, 2013 (in the US via UPS overnight service, 1-day delivery). Customers are requested to return a Confirmation Certificate confirming
their receipt of the notification. 100% customer confirmations will be required from the additional consignees.
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
Occluder, catheter tip - Product Code DQT
Causa
Potential for ptfe (polytetrafluroethylene) coating to delaminate and detach from guidewire.
Acción
The firm, Medtronic, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 21, 2013 (in the US via UPS overnight service, 1-day delivery) to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove and quarantine all potentially affected guidewires that remain in inventory; return the affected product to Medtronic; if replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product, and to complete and return the Customer Confirmation Certificate confirming receipt of the notification via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality (100% customer confirmations will be required).
Should have any questions, please contact your Medtronic Representative or call 763-526-2513.
Notifications to customers concerning the additional affected product began December 19, 2013 (in the US via UPS overnight service, 1-day delivery). Customers are requested to return a Confirmation Certificate confirming
their receipt of the notification. 100% customer confirmations will be required from the additional consignees.
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.
Southern implants is recalling the tri-nex healing abutment because the package was incorrectly labeled and packaged as the tri-nex healing abutment, 05.0 mm x 5 mm height (ha-l-50-5). the package contains the tri-nex healing abutment 05.0 mm x 6.0 mm flare x 5 mm height (ha-l-50w-5).
Acción
Southern Implants, Inc. sent an Urgent Product Action letter dated September 11, 2013, to all affected customers. The letter identiied the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out the customer response form and fax/email the completed form to Customer Support at (866) 903-9272 or customersupport@keystonedental.com.
For questions regarding this recall call 866-903-9272.
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.
Intuitive has identified that the metalized coating on the is3000 hd lamp module may be incompatible with the illuminator control board, leading to an erroneous red preventive maintenance message that shows up on monitors.
Acción
Intuitive Surgical sent an Urgent Medical Device Correction letter dated October 23, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to open the illuminator and replace any metal-finish lamp modules with plastic finish lamp modules, if customers do not have a replacement plastic-finish lamp module available, they may continue to use the metal-finish lamp module until they receive a replacement. If the message "illuminator lamp module error: Please reseat or replace lamp module" is displayed on the patient side monitor and the surgeon console, contact intuitive Surgical Customer Service. Customers were also instructed to examine any remaining or spare inventory to identify any metal-finish lamp modules and return them to Intuitive Surgical for credit. Customers were instructed to ensure all affected personnel are fully informed of this Urgent Medical Device Corrrection letter. Customers should complete the attached Acknowledgement Form and return it to Intuitive Surgical as instructed. Customers with questions should contact Intuitive Surgical Customer Service.
For questions regarding this recall call 408-523-2244.
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
Appliance, fixation, spinal intervertebral body - Product Code KWQ
Causa
Depuy synthes is initiating a voluntary medical device recall of certain lots of the ti vectra plates, which is a part of the depuy synthes vectra anterior cervical plate family of systems. the vectra systems are intended for anterior screw fixation to the cervical spine (c2-c7). it was discovered in certain lots, that the clips are potentially missing from the ti vectra plates resulting in the i.
Acción
DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated September 2, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Please take the following actions:
If you DO have any of the identified devices, please take the following steps: Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. Return the Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Send a copy of the completed Verification Section to DePuy Synthes by: Fax: (610) 430-7083 or Scan/email: Fieldaction@synthes.com
If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section (page 3 of this letter) by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical information. Return the documents to DePuy Synthes by: Fax: (610) 430-7083 or Scan/email: Fieldaction@sythes.com Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 3 of the notification.
If you have any questions, please call 610-719-5450, or contact your DePuy Synthes sales consultant.
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
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
Causa
St. jude medical cardiovascular and ablation technologies division is performing a voluntary notification regarding selected batched of safire duo ablation catheter mediguide enabled. these units have a cable connector configuration that is different than intended.
Acción
Consignees were sent a St. Jude Medical "Urgent Medical Device Notice" dated 11 October 2013. The letter was addressed to Cath lab manger / Risk Manger. The letter described the problem and the product involved in the recall. The letter stated that it is acceptable to continue using these devices as long as the product is used in accordance with the IFU.