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
Cardiopulmonary resuscitation aid kit - Product Code OEV
Causa
The mask component on various lots of the resuscitation devices have been identified as having the
potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the
mask from the elbow of the resuscitator.
Acción
The firm, Vyaire Medical, sent an "URGENT RECALL NOTICE" letter on 04/27/2017 and again on 06/08/2017 for the expansion of the recall to its Customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect current inventory on-hand and immediately perform a 1OO% physical inventory of the product to identify and be removed; complete and return the Customer Response Form by Fax to: (312) 949.0972 or email to:GMB-GLB-VSFieldActions@CareFusion.com.; destroy all affected product in accordance with your facility's destruction protocol; and for replacements, contact your distributor Armstrong Medical direct at (800)323.4220 x129.
For any additional questions and support concerning this voluntary recall, please contact Customer Advocacy Analyst at (224) 706.6829 or email: Kristina.Scheppa@CareFusion.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.
Notas adicionales en la data
Cardiopulmonary resuscitation aid kit - Product Code OEV
Causa
The mask component on various lots of the resuscitation devices have been identified as having the
potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the
mask from the elbow of the resuscitator.
Acción
The firm, Vyaire Medical, sent an "URGENT RECALL NOTICE" letter on 04/27/2017 and again on 06/08/2017 for the expansion of the recall to its Customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect current inventory on-hand and immediately perform a 1OO% physical inventory of the product to identify and be removed; complete and return the Customer Response Form by Fax to: (312) 949.0972 or email to:GMB-GLB-VSFieldActions@CareFusion.com.; destroy all affected product in accordance with your facility's destruction protocol; and for replacements, contact your distributor Armstrong Medical direct at (800)323.4220 x129.
For any additional questions and support concerning this voluntary recall, please contact Customer Advocacy Analyst at (224) 706.6829 or email: Kristina.Scheppa@CareFusion.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.
Notas adicionales en la data
Cardiopulmonary resuscitation aid kit - Product Code OEV
Causa
The mask component on various lots of the resuscitation devices have been identified as having the
potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the
mask from the elbow of the resuscitator.
Acción
The firm, Vyaire Medical, sent an "URGENT RECALL NOTICE" letter on 04/27/2017 and again on 06/08/2017 for the expansion of the recall to its Customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect current inventory on-hand and immediately perform a 1OO% physical inventory of the product to identify and be removed; complete and return the Customer Response Form by Fax to: (312) 949.0972 or email to:GMB-GLB-VSFieldActions@CareFusion.com.; destroy all affected product in accordance with your facility's destruction protocol; and for replacements, contact your distributor Armstrong Medical direct at (800)323.4220 x129.
For any additional questions and support concerning this voluntary recall, please contact Customer Advocacy Analyst at (224) 706.6829 or email: Kristina.Scheppa@CareFusion.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.
Notas adicionales en la data
Cardiopulmonary resuscitation aid kit - Product Code OEV
Causa
The mask component on various lots of the resuscitation devices have been identified as having the
potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the
mask from the elbow of the resuscitator.
Acción
The firm, Vyaire Medical, sent an "URGENT RECALL NOTICE" letter on 04/27/2017 and again on 06/08/2017 for the expansion of the recall to its Customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect current inventory on-hand and immediately perform a 1OO% physical inventory of the product to identify and be removed; complete and return the Customer Response Form by Fax to: (312) 949.0972 or email to:GMB-GLB-VSFieldActions@CareFusion.com.; destroy all affected product in accordance with your facility's destruction protocol; and for replacements, contact your distributor Armstrong Medical direct at (800)323.4220 x129.
For any additional questions and support concerning this voluntary recall, please contact Customer Advocacy Analyst at (224) 706.6829 or email: Kristina.Scheppa@CareFusion.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.
Notas adicionales en la data
Staple, implantable - Product Code GDW
Causa
Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Acción
On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423.
The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
All in-control inventory and devices returned from customers will be reworked.
**FOR INTERNATIONAL CUSTOMERS**
Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter.
Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO:
- "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140.
- "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.
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
Cardiopulmonary resuscitation aid kit - Product Code OEV
Causa
The mask component on various lots of the resuscitation devices have been identified as having the
potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the
mask from the elbow of the resuscitator.
Acción
The firm, Vyaire Medical, sent an "URGENT RECALL NOTICE" letter on 04/27/2017 and again on 06/08/2017 for the expansion of the recall to its Customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect current inventory on-hand and immediately perform a 1OO% physical inventory of the product to identify and be removed; complete and return the Customer Response Form by Fax to: (312) 949.0972 or email to:GMB-GLB-VSFieldActions@CareFusion.com.; destroy all affected product in accordance with your facility's destruction protocol; and for replacements, contact your distributor Armstrong Medical direct at (800)323.4220 x129.
For any additional questions and support concerning this voluntary recall, please contact Customer Advocacy Analyst at (224) 706.6829 or email: Kristina.Scheppa@CareFusion.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.
Notas adicionales en la data
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. in the worst case scenario, the plunger may crack leading to impaired syringe function.
Acción
On April 3, 2018, The Firm sent an Urgent Medical Device Correction letter via UPS Ground.
Consignees were notified of the possible failure. Consignees were informed that a Roche representative would contact them to install a syringe plunger guide for the affected syringes to resolve the issue. In the meantime, consignees were instructed to only measure assays that do not require prewash steps and assays that are not impacted by missing prewash step until the syringe plunger guide is installed on the affected module. If the customer identifies broken syringe plungers on their device, the notice instructed them to contact the Roche Support Network Customer Support Center at 1-800-428-2336, available 24 hours a day, 7 days a week. Customers were asked to complete a customer response form and return it to the firm.
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
Accessory equipment, cardiopulmonary bypass - Product Code KRI
Causa
There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
Acción
The Urgent Medical Device Recall Removal letter was distributed on 4/4/18. The letter instructed the customer to:
Please examine your inventory for the affected 701050901 Gas Bottle Holder HKH 8880 and immediately remove it from use.
Please contact your Getinge representative or call the Maquet/Getinge Customer Support at +1 (888) 627-8383 (press option 2, then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) to obtain instructions on returning the affected product for a full credit.
Please complete and sign the attached MEDICAL DEVICE RECALL - RESPONSE FORM (page 3) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to fieldactions@maquet.com or by faxing the form to +1 (973) 629-1655.
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
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.
Acción
On 4/3/18, Baxter HealthCare Corporation mailed URGENT MEDICAL DEVICE CORRECTION notices and Reply Forms to customers via first class mail.
Actions to be Taken by Customers:
1. Locate and discontinue use of all affected pumps at your facility.
2. Return the device to Baxter for testing. To arrange for return of affected devices, contact Baxter at 800-356-3454 between the hours of 7:00 am and 7:00 pm Eastern Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, serial number, and quantity of devices to be returned ready when calling.
3. If you purchased this product directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or via email to fca@baxter.com even if you do not have inventory.
4. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions.
5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them.
6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers.
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
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.
Acción
On 4/3/18, Baxter HealthCare Corporation mailed URGENT MEDICAL DEVICE CORRECTION notices and Reply Forms to customers via first class mail.
Actions to be Taken by Customers:
1. Locate and discontinue use of all affected pumps at your facility.
2. Return the device to Baxter for testing. To arrange for return of affected devices, contact Baxter at 800-356-3454 between the hours of 7:00 am and 7:00 pm Eastern Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, serial number, and quantity of devices to be returned ready when calling.
3. If you purchased this product directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or via email to fca@baxter.com even if you do not have inventory.
4. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions.
5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them.
6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers.
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.
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
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.
Acción
On 4/3/18, Baxter HealthCare Corporation mailed URGENT MEDICAL DEVICE CORRECTION notices and Reply Forms to customers via first class mail.
Actions to be Taken by Customers:
1. Locate and discontinue use of all affected pumps at your facility.
2. Return the device to Baxter for testing. To arrange for return of affected devices, contact Baxter at 800-356-3454 between the hours of 7:00 am and 7:00 pm Eastern Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, serial number, and quantity of devices to be returned ready when calling.
3. If you purchased this product directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or via email to fca@baxter.com even if you do not have inventory.
4. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions.
5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them.
6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers.
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
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.
Acción
On 4/3/18, Baxter HealthCare Corporation mailed URGENT MEDICAL DEVICE CORRECTION notices and Reply Forms to customers via first class mail.
Actions to be Taken by Customers:
1. Locate and discontinue use of all affected pumps at your facility.
2. Return the device to Baxter for testing. To arrange for return of affected devices, contact Baxter at 800-356-3454 between the hours of 7:00 am and 7:00 pm Eastern Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, serial number, and quantity of devices to be returned ready when calling.
3. If you purchased this product directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or via email to fca@baxter.com even if you do not have inventory.
4. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions.
5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them.
6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers.
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
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.
Acción
On 4/3/18, Baxter HealthCare Corporation mailed URGENT MEDICAL DEVICE CORRECTION notices and Reply Forms to customers via first class mail.
Actions to be Taken by Customers:
1. Locate and discontinue use of all affected pumps at your facility.
2. Return the device to Baxter for testing. To arrange for return of affected devices, contact Baxter at 800-356-3454 between the hours of 7:00 am and 7:00 pm Eastern Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, serial number, and quantity of devices to be returned ready when calling.
3. If you purchased this product directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or via email to fca@baxter.com even if you do not have inventory.
4. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions.
5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them.
6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers.
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
The dc power to the ifoss collision detector control panel at your facility is being adversely affected by the magnetic field. our investigation shows the magnetic field is causing the ifoss control panel to malfunction.
Acción
IMRIS sent Service bulletin T200627-B01 Rev dated March 14, 2018. - through email to all affected customers. The letter identified the affected product, the problem, and the actions required to be taken by the customer. For questions contact IMRIS Customer Support 866-475-0525.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.