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 firm is initiating a recall due to the potential for breakdown of the altin pvd (black) coating during surgery and the coating could fall into the surgical site. the firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
Acción
The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
Instructions for Handling of Affected Product:
1) Stop using the devices and to quarantine immediately
2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder
3)Ensure they have provided acknowledgement via "email return receipt" upon receiving this notification
4) Fax copy of completed form to (574) 372-4265
5) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580
A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available.
Instructions for Health Care Professional Notification
1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form
2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265
Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a "Dear Doctor" letter for their surgeons.
Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions.
For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131.
ADDENDUM INFO
The information listed above was updated to include the additional 5
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.
Xio software: under certain conditions, when the port shape is altered, dose is not recalculated. the port-change flag is not being set correctly when the port shape is regenerated. the dose distribution will not match the blocking displayed and the mis-match might not be obvious. monitor unit calculations will also be based on an incorrect dose distribution. this problem has existed since re.
Acción
Computerized Medical Systems, Inc. sent a "XiO CUSTOMER ADVISORY" letter dated December 8, 2008 to all affected customers. The advisory describes the product, problem, and the actions to be taken. The customers were instructed to set the prompt to "Yes" to avoid the problem from occurring according to written instructions provided in the advisory. This problem has existed since Release 4.3.1 and is expected to be resolved with XiO Release 4.50.00.
Questions should be directed to the manufacturer's representative at 408-830-8023.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Arthroscope - Product Code HBX
Causa
Product sterility may be compromised due to breach in sterile packaging.
Acción
Depuy Mitek sent an Urgent Voluntary Product Recall letter dated December 2, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to isolate all inventory of the affected product and call 1-800-382-4682, PROMPT 3, for return good authorization and replacement product.
Customers were instructed to return all identified affected product to:
DePuy Mitek
ATTN: Recall Coordinator
50 Scotland Boulevard
Bridgewater, MA 02324
Record their assigned return material authorization (RMA) number on the outer shipping box.
Use the Prepaid Federal Express shipping label for the return of the product.
Include a photo copy of the completed business reply form.
For questions or concerns call 1-800-382-4682, PROMPT 3.
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.
Interplant software: if the trajectory needle with a non-zero retraction is adjusted in any of the planning views (transverse, 3d) and the program is closed and reopened, the needle definitions page in the dose plan summary (plan view) displays the needle with a 0.00 retraction even when the needle is displayed correctly in the planning view. if the eliminate leading spacers function is applied t.
Acción
Computerized Medical Systems, Inc. sent a "CUSTOMER ADVISORY" letter dated December 1, 2008, to all affected customers. The letter identified the product, the problem, and the actions to be taken. Customers were instructed to discontinue use of the product. There is no workaround at this time. This issue was resolved in Interplant Release 3.4.1 software. All possibly affected users have been shipped the Interplant Release 3.4.1 software in May 2010.
If you have any questions, please call 314-993-0003 or toll free 800-878-4267.
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.
Monaco: if the user selects monte carlo photon as the secondary algorithm (to be used for final dose calculation through segments), and selects skip forward button at any time during stage 2 optimization, the system may only use the pencil beam algorithm for final computation of dose even though monte carlo was selected. other than specific output to the console window, there will be no other in.
Acción
Computerized Medical Systems, Inc. sent a "MONACO CUSTOMER ADVISORY" letter dated June 2008 to all affected customers. The letter describes the product, problem, and the action to be taken. The customer was instructed to use caution when using the Skip Forward button in stage 2 according to written instructions provided in the letter.
This defect exists in Monaco Release 1.0.0 through 1.0.2 and will be resolved as soon as possible. Note: The issue was resolved in Monaco Release 2.0.1 and above.
Questions should be directed to the manufacturer's representative telephone number at 408-830-8023.
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
Accelerator, linear, medical - Product Code IYE
Causa
A software anomaly, in that the multileaf collimator (mlc) message displayed on the 4ditc on versions 8.6 and below, does not interlock beam delivery.
Acción
Varian Medical Systems sent an Urgent Medical Device Correction Letter on February 28, 2011, to all affected customers.
Varian has created the procedure described in CTB-GE-579 to inform users on proper interfacing of the demountable BrainLAB m3 on the Varian Clinac. The procedure ( CTB-GE-579) is enclosed and posted to the customer site: http://www.MyVarian.com.
This design fix in 4DITC v10.1 or later will be provided to all affected sites.
If you require further clarification, please feel free to contact your local Varian Customer Support District or Regional Manager.
USA and Canada - 1-888-VARIANS (888-827-4265)
Europe - + 41 41 749 8844
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 firm is initiating a recall due to the potential for breakdown of the altin pvd (black) coating during surgery and the coating could fall into the surgical site. the firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
Acción
The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
Instructions for Handling of Affected Product:
1) Stop using the devices and to quarantine immediately
2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder
3)Ensure they have provided acknowledgement via "email return receipt" upon receiving this notification
4) Fax copy of completed form to (574) 372-4265
5) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580
A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available.
Instructions for Health Care Professional Notification
1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form
2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265
Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a "Dear Doctor" letter for their surgeons.
Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions.
For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131.
ADDENDUM INFO
The information listed above was updated to include the additional 5
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 firm is initiating a recall due to the potential for breakdown of the altin pvd (black) coating during surgery and the coating could fall into the surgical site. the firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
Acción
The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
Instructions for Handling of Affected Product:
1) Stop using the devices and to quarantine immediately
2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder
3)Ensure they have provided acknowledgement via "email return receipt" upon receiving this notification
4) Fax copy of completed form to (574) 372-4265
5) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580
A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available.
Instructions for Health Care Professional Notification
1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form
2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265
Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a "Dear Doctor" letter for their surgeons.
Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions.
For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131.
ADDENDUM INFO
The information listed above was updated to include the additional 5
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
Ultrasonic Pulsed Doppler Imaging System - Product Code IYN
Causa
The firm discovered a software error on the accuson s2000 ultrasound systems affecting the measurement results in the patient report.
Acción
Siemens issued a Customer Safety Advisory Notification letter to all customers on March 15, 2011, regarding a software error on the ACUSON S2000 ultrasound systems affected measurement . They are in the process of releasing a software update that will correct this issue. Siemens recommends reviewing the patient report at the end of each study to confirm that the report contains only measurements relevant to the exam just performed.
No patient injury has been reported.
Further questions regarding this recall please call (650) 694-5398.
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 firm is initiating a recall due to the potential for breakdown of the altin pvd (black) coating during surgery and the coating could fall into the surgical site. the firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
Acción
The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
Instructions for Handling of Affected Product:
1) Stop using the devices and to quarantine immediately
2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder
3)Ensure they have provided acknowledgement via "email return receipt" upon receiving this notification
4) Fax copy of completed form to (574) 372-4265
5) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580
A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available.
Instructions for Health Care Professional Notification
1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form
2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265
Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a "Dear Doctor" letter for their surgeons.
Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions.
For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131.
ADDENDUM INFO
The information listed above was updated to include the additional 5
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 firm is initiating a recall due to the potential for breakdown of the altin pvd (black) coating during surgery and the coating could fall into the surgical site. the firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
Acción
The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
Instructions for Handling of Affected Product:
1) Stop using the devices and to quarantine immediately
2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder
3)Ensure they have provided acknowledgement via "email return receipt" upon receiving this notification
4) Fax copy of completed form to (574) 372-4265
5) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580
A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available.
Instructions for Health Care Professional Notification
1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form
2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265
Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a "Dear Doctor" letter for their surgeons.
Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions.
For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131.
ADDENDUM INFO
The information listed above was updated to include the additional 5
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
Needle, Hypodermic, Single Lumen - Product Code FMI
Causa
Needle cannula may separate from the hub during use.
Acción
Recall letters requesting product return were mailed to all customers on October 8, 2004
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 firm is initiating a recall due to the potential for breakdown of the altin pvd (black) coating during surgery and the coating could fall into the surgical site. the firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
Acción
The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
Instructions for Handling of Affected Product:
1) Stop using the devices and to quarantine immediately
2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder
3)Ensure they have provided acknowledgement via "email return receipt" upon receiving this notification
4) Fax copy of completed form to (574) 372-4265
5) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580
A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available.
Instructions for Health Care Professional Notification
1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form
2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265
Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a "Dear Doctor" letter for their surgeons.
Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions.
For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131.
ADDENDUM INFO
The information listed above was updated to include the additional 5
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 firm is initiating a recall due to the potential for breakdown of the altin pvd (black) coating during surgery and the coating could fall into the surgical site. the firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
Acción
The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
Instructions for Handling of Affected Product:
1) Stop using the devices and to quarantine immediately
2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder
3)Ensure they have provided acknowledgement via "email return receipt" upon receiving this notification
4) Fax copy of completed form to (574) 372-4265
5) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580
A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available.
Instructions for Health Care Professional Notification
1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form
2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265
Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a "Dear Doctor" letter for their surgeons.
Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions.
For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131.
ADDENDUM INFO
The information listed above was updated to include the additional 5
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 firm is initiating a recall due to the potential for breakdown of the altin pvd (black) coating during surgery and the coating could fall into the surgical site. the firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
Acción
The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
Instructions for Handling of Affected Product:
1) Stop using the devices and to quarantine immediately
2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder
3)Ensure they have provided acknowledgement via "email return receipt" upon receiving this notification
4) Fax copy of completed form to (574) 372-4265
5) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580
A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available.
Instructions for Health Care Professional Notification
1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form
2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265
Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a "Dear Doctor" letter for their surgeons.
Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions.
For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131.
ADDENDUM INFO
The information listed above was updated to include the additional 5
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 firm is initiating a recall due to the potential for breakdown of the altin pvd (black) coating during surgery and the coating could fall into the surgical site. the firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
Acción
The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
Instructions for Handling of Affected Product:
1) Stop using the devices and to quarantine immediately
2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder
3)Ensure they have provided acknowledgement via "email return receipt" upon receiving this notification
4) Fax copy of completed form to (574) 372-4265
5) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580
A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available.
Instructions for Health Care Professional Notification
1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form
2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265
Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a "Dear Doctor" letter for their surgeons.
Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions.
For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131.
ADDENDUM INFO
The information listed above was updated to include the additional 5
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 firm is initiating a recall due to the potential for breakdown of the altin pvd (black) coating during surgery and the coating could fall into the surgical site. the firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
Acción
The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
Instructions for Handling of Affected Product:
1) Stop using the devices and to quarantine immediately
2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder
3)Ensure they have provided acknowledgement via "email return receipt" upon receiving this notification
4) Fax copy of completed form to (574) 372-4265
5) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580
A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available.
Instructions for Health Care Professional Notification
1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form
2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265
Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a "Dear Doctor" letter for their surgeons.
Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions.
For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131.
ADDENDUM INFO
The information listed above was updated to include the additional 5
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 firm is initiating a recall due to the potential for breakdown of the altin pvd (black) coating during surgery and the coating could fall into the surgical site. the firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
Acción
The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
Instructions for Handling of Affected Product:
1) Stop using the devices and to quarantine immediately
2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder
3)Ensure they have provided acknowledgement via "email return receipt" upon receiving this notification
4) Fax copy of completed form to (574) 372-4265
5) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580
A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available.
Instructions for Health Care Professional Notification
1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form
2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265
Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a "Dear Doctor" letter for their surgeons.
Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions.
For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131.
ADDENDUM INFO
The information listed above was updated to include the additional 5
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 firm is initiating a recall due to the potential for breakdown of the altin pvd (black) coating during surgery and the coating could fall into the surgical site. the firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.
Acción
The firm, Zimmer, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 14, 2011 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
Instructions for Handling of Affected Product:
1) Stop using the devices and to quarantine immediately
2) Carry out a physical count of all affect product in their territory and record data on Inventory Identification Form included with this letter-Note: The instruments must be returned even if the instrument is not exhibiting the black powder
3)Ensure they have provided acknowledgement via "email return receipt" upon receiving this notification
4) Fax copy of completed form to (574) 372-4265
5) Return the recalled product along with the completed Inventory Identification Form and the Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580
A new or refurbished instrument will be provided as replacement for their returned product once the inventory is available.
Instructions for Health Care Professional Notification
1) Provide a list of all hospital that currently use or have used the affected product listed in notice by utilizing the User Facility Documentation Form and the Health Care Professional Documentation Form
2) Fax a copy of the completed form(s) to: Zimmer, Inc. at (574) 372-4265
Zimmer will provide a similar notification via FedEx to these hospitals making them aware of this recall and provide a "Dear Doctor" letter for their surgeons.
Important: If you have distributed these affected lots further, please provide a copy of this letter to these customers when you implement these recall instructions.
For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc., at 1-800-613-6131.
ADDENDUM INFO
The information listed above was updated to include the additional 5
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.
Focal: in absolute dose mode a beam with a port may be calculated with open normalization, with the result that the displayed dose reflects open normalization while the monitor units and qa plan reflect blocked normalization. this is particularly important when these beams also include compensators. the problem is detectable by looking at the delivered dose to the weight point in the patient as.
Acción
Computerized Medical Systems Inc sent a "CUSTOMER ADVISORY" letter dated March 2008 to all affected customers. The letter describes the product, the problem and the actions to be taken. The firm provided a workaround for customers that states "Alternatively the plan can be imported directly into XIO". A copy of the Advisory was shipped with software within the affected range to those requesting a software upgrade.
The issue was resolved in Focal Release 4.40.00 introduced in June 2008.
The firm will send out a User Notice to all sites still running affected software to remind them that the issue resolution is available.
For further questions, please call (403) 830-8023.
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
Counter, differential cell - Product Code GKZ
Causa
The recall was initiated because:
specimen tubes may fall out of a type a cassette (pn a53551, kit of 20) when the analyzer inverts the cassette in the mixing station, or when an operator manually inverts a cassette
the impact:
- specimen tubes may fall out of cassettes and be misplaced inside the instrument
- specimen tubes may break upon impact, causing possible biohazard exposure
- patien.
Acción
Beckman Coulter initiated a Product Corrective Action (PCA) letter with attached Recall Response Form being sent via US Postal Service on February 11, 2011 to all customers who have the affected instruments. Customers were informed of the reasons for recall, products affected and resolution for these issues would be corrected in a future release(s) for the DxH 800; but were also asked to take the following actions:
-Periodically inspect the mix station drip tray for misplaced tubes that may have fallen from the cassette.
- Periodically examine the Type A cassettes to determine if the expandable grippers (clips) within the lavender-colored insert are stuck in the open position (tubes will be loose). Consignees were told to contact their Beckman Coulter representative for assistance with questionable grippers.
- Clean any spills according to their laboratory standard operating procedures.
Consignees were requested to complete and return the enclosed Response Form within ten (10) days and to share this information with their laboratory staff and retain the notification as part of their Quality System documentation. If consignees have transferred ownership or location of the analyzer(s) to another laboratory, they were requested to provide a copy of the letter to that party. For questions concerning this notice, consignees were told to contact Beckman Coulter Customer Service at 800-526- 7694 in the United States or Canada, or contact their local Beckman Coulter representative.
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
Red-Cell lysing products - Product Code GGK
Causa
The recall was initiated by beckman coulter because the coulter lyse iii diff lytic reagent lot number 101554f was released for distribution to customers between november 17 and december 1, 2010 prior to completion of qc testing.
Acción
Beckman Coulter sent a Product Corrective Action ( PCA) letter dated December 28, 2010, to all affected consignees with an attached PCA Response form via US Postal Service for US Customers) who purchased the Coulter Lyse S III diff Lytic Lot # 101554F. The letter provides customers with an explanation of the problem identified and an action to be taken.
If customers currently had any of the lot mentioned above in their laboratory, they were asked to discontinue use and discard remaining product according to their laboratory chemical safety procedures. And to complete and return the enclosed response form within 10 days to acknowledge that they received this notice and are taking appropriate action.
For the population at most risk, there is no serious consequences and only remote probability of injury and medically reversible consequences due by the small change for Hgb and WBC results.
Consignees were also asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation.
Technical questions regarding this Product Corrective Action were directed to Beckman Coulter Customer Service at( 800) -526-7694 in the United States and Canada.
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, bone - Product Code JEY
Causa
Biomet microfixation, jacksonville, fl is recalling their 1.5 6 hole reg double y, lots 785710, 753120, 693500 and 733600. this product is labeled as 01-7110-k (1.5 6 hole reg double y), however the package contains a 01-7112-k (1.5.6 hold long double y).
Acción
The firm, Biomet Microfixation, sent an "URGENT MEDICAL SAFETY ALERT NOTICE" letter dated July 28, 2010 to its customers/distributors. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their stock and ensure that the plates were properly distributed into their trays and that they have the sufficient quantity of plates that they need. In addition, they were instructed to complete and return the attached Inventory Reconciliation form via fax to: Attn: Customer Relations Specialist at 904-741-9425 and notify the recipient of this notice, if they have further distributed the product.
If you have any questions, please contact the Customer Relations Specialist at 800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.
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
Accelerator, linear, medical - Product Code IYE
Causa
The wedge angle labeling on the wedge tray may not correctly match the wedge body. however, the wedge body is labeled with the correct wedge angle.
Acción
The firm, Varian Medical, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated February 24, 2011, to all affected users. The letter described the product, problem and actions to be taken. The customers were instructed to IMMEDIATELY inspect all wedges to verify that the wedge angle label on the wedge body matches the wedge angle on the wedge tray; if any wedge is identified with mismatched labeling follow the written instructions provided in the letter; always measure wedge data at installation of new or replacement wedges; verify all treatment accessories of "matched" linear accelerators, and please advise the appropriate personnel working in your Radiotherapy Department of the content of this letter.
Varian has enhanced their manufacturing quality control process to further ensure correct labeling of wedges. Also, Varian will replace any wedge that is identified as mislabeled, at the request of the customer.
If you require further clarification, please feel free to contact your local Varian Customer Support Service Manager at: 1-888-VARIAN5 (888-827-4265) for USA and Canada; +14 41 749 8844 Europe; North American: support-americas@varian.com; Australia/New Zealand:support-anz@varian.com; Europe: support-emea@varian.com; South East Asia: seasia.apps.helpdesk@varian.com; China/Asia: china.apps.helpdesk@varian.com; Japan: Japan.apps.helpdesk@varian.com; Latin America:soporte.al@varian.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
Needle, suturing, disposable - Product Code GAB
Causa
The firm initiated a recall due to the discovery that the devices were not sterilized, as required, prior to distribution.
Acción
The firm, BIOMET, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated March 10, 2011 to all customers. The letter described the product, problem and actions to be taken. The letter noted that -Use of a non-sterile Curvtek Eye Needle may lead to patient infection, possibly requiring a revision procedure. The customers were instructed to immediately locate, discontinue use of the product , remove the product from circulation and return the product to Biomet; carefully follow the instructions on the enclosed FAX BACK RESPONSE FORM; complete and return the response form via fax to 574-372-1683 prior to return of product; use priority carrier for shipment, and please confirm receipt of this notice by calling 800-348-9500, extension 3755 or 3756. The firm also informed physicians that had previously utilized the device to monitor patients for infection and provide treatment as appropriate.
Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8am to 5pm.