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
hip prosthesis - Product Code KWY
Causa
Device mislabeled. hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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
hip prosthesis - Product Code KWY
Causa
Device mislabeled. hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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
hip prosthesis - Product Code KWY
Causa
Device mislabeled. hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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
hip prosthesis - Product Code KWY
Causa
Device mislabeled. hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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
hip prosthesis - Product Code KWY
Causa
Device mislabeled. hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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
hip prosthesis - Product Code KWY
Causa
Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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
hip prosthesis - Product Code KWY
Causa
Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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
hip prosthesis - Product Code KWY
Causa
Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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.
Devices mislabeled; one lot of size 36 standard rsp socket inserts were labeled as size 40 standard rsp sockets and vice versa.
Acción
Encore notified their sales reps (direct accounts) via telephone and overnight letter on 08/08/07. Encore sales reps were asked to return all outstanding devices, for which they would be given replacements. Notification of implanting surgeons was done by phone and letter (Urgent : Device Recall) between 08/07 and 09/12/07. Implanting surgeons notified of recall and asked to closely monitor patients who had received and already been implanted with the affected lots. If explant was required decision of the surgeons, they were asked to notify the recalling 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
hip prosthesis - Product Code KWY
Causa
Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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
hip prosthesis - Product Code KWY
Causa
Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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
hip prosthesis - Product Code KWY
Causa
Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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
hip prosthesis - Product Code KWY
Causa
Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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
hip prosthesis - Product Code KWY
Causa
Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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
hip prosthesis - Product Code KWY
Causa
Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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
hip prosthesis - Product Code KWY
Causa
Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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
hip prosthesis - Product Code KWY
Causa
Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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
hip prosthesis - Product Code KWY
Causa
Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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
hip prosthesis - Product Code KWY
Causa
Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
Acción
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.
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.
Devices mislabeled; one lot of size 36 standard rsp socket inserts were labeled as size 40 standard rsp sockets and vice versa.
Acción
Encore notified their sales reps (direct accounts) via telephone and overnight letter on 08/08/07. Encore sales reps were asked to return all outstanding devices, for which they would be given replacements. Notification of implanting surgeons was done by phone and letter (Urgent : Device Recall) between 08/07 and 09/12/07. Implanting surgeons notified of recall and asked to closely monitor patients who had received and already been implanted with the affected lots. If explant was required decision of the surgeons, they were asked to notify the recalling 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
Apical Hole Plug - Product Code LPH
Causa
Incorrect or lack of threading: the plug component was manufactured incorrectly and does not fit with the screw hole as intended.
Acción
The distributor was notified via phone on or about 8/9/07 and by letter dated 8/31/07 and requested to return the product. Returns included subaccounts
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
Stabilized Tibial Insert - Product Code NJL
Causa
An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Acción
Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.
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
Stabilized Tibial Insert - Product Code NJL
Causa
An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Acción
Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.
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
Stabilized Tibial Insert - Product Code NJL
Causa
An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Acción
Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.
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
Stabilized Tibial Insert - Product Code NJL
Causa
An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Acción
Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.