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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
bone cutting tool - Product Code HBE
Causa
Lack of assurance of sterility.
Acción
Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
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
Endovascular Stent - Product Code MIH
Causa
Sterility compromised: device sterility may be compromised as evidenced by a loss of outer package integrity.
Acción
Medtronic sent Urgent Communication - Medical Device Correction Advisory Notice letters to all its direct consignees on 12/7/07, via Federal Express, informing them of the affected product and providing instructions on avoiding contamination of the sterile surgical field with these devices.
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
Precision attachment - Product Code EGG
Causa
Mislabeled package: narrow connection (nc) closure screws contain closure screws for the regular connection (rc) bone level implant. the rc closures screw is larger (3.5mm diameter) and therefore, will not fit into the nc implant (3.0mm diameter) narrow connection.
Acción
Consignees were notified by telephone on 1/10/08 followed by an Urgent Device Recall letter on January 10, 2008. The letter instructs users to return any affected product to the firm along with a recall acknowledgement form. For additional information, contact 978-747-2514.