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.
Notes supplémentaires dans les données
Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment - Product Code KIJ
Cause
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Action
Consignees were notified of the problem via letter dated October 10, 2008, provided interim instructions to reduce the risk, and informed that Stryker instruments will replace the trigger on all handpieces. Consignees were also instructed on the following: 1) Review the letter and distribute to all affected departments, 2) Complete and sign the enclosed Business Reply Form and fax to 336-499-8603 and 3) Call Stryker Instruments Service Department at 888-308-1983 to schedule service for the handpieces.
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.
Notes supplémentaires dans les données
Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment - Product Code KIJ
Cause
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Action
Consignees were notified of the problem via letter dated October 10, 2008, provided interim instructions to reduce the risk, and informed that Stryker instruments will replace the trigger on all handpieces. Consignees were also instructed on the following: 1) Review the letter and distribute to all affected departments, 2) Complete and sign the enclosed Business Reply Form and fax to 336-499-8603 and 3) Call Stryker Instruments Service Department at 888-308-1983 to schedule service for the handpieces.
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.
Notes supplémentaires dans les données
Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment - Product Code KIJ
Cause
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Action
Consignees were notified of the problem via letter dated October 10, 2008, provided interim instructions to reduce the risk, and informed that Stryker instruments will replace the trigger on all handpieces. Consignees were also instructed on the following: 1) Review the letter and distribute to all affected departments, 2) Complete and sign the enclosed Business Reply Form and fax to 336-499-8603 and 3) Call Stryker Instruments Service Department at 888-308-1983 to schedule service for the handpieces.
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.
Notes supplémentaires dans les données
Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment - Product Code KIJ
Cause
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Action
Consignees were notified of the problem via letter dated October 10, 2008, provided interim instructions to reduce the risk, and informed that Stryker instruments will replace the trigger on all handpieces. Consignees were also instructed on the following: 1) Review the letter and distribute to all affected departments, 2) Complete and sign the enclosed Business Reply Form and fax to 336-499-8603 and 3) Call Stryker Instruments Service Department at 888-308-1983 to schedule service for the handpieces.
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.
Notes supplémentaires dans les données
Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment - Product Code KIJ
Cause
The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.
Action
Consignees were notified of the problem via letter dated October 10, 2008, provided interim instructions to reduce the risk, and informed that Stryker instruments will replace the trigger on all handpieces. Consignees were also instructed on the following: 1) Review the letter and distribute to all affected departments, 2) Complete and sign the enclosed Business Reply Form and fax to 336-499-8603 and 3) Call Stryker Instruments Service Department at 888-308-1983 to schedule service for the handpieces.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
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.
Notes supplémentaires dans les données
hip prosthesis component. - Product Code JDG
Cause
Packaging mix up between the taper v40 femoral head and the lfit v40 femoral head.
Action
Stryker sent Notification letters and Product Accountability Forms via FedEx on September 4, 2009 with return receipt. Corrected letters were sent on September 9, 2009.
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.
Notes supplémentaires dans les données
hip prosthesis component. - Product Code JDG
Cause
Packaging mix up between the taper v40 femoral head and the lfit v40 femoral head.
Action
Stryker sent Notification letters and Product Accountability Forms via FedEx on September 4, 2009 with return receipt. Corrected letters were sent on September 9, 2009.
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.
A lot for lot mix up occurred between the triathlon total knee system primary tibial baseplate # 4 cemented, catalog # 5520-b-400, lot sh8nt and the #2 cemented, catalog # 5520-b-200, lot sh7rp.
Action
The firm, Stryker Orthopaedics, sent an "URGENT PRODUCT RECALL" letter dated September 1, 2009, via FedEx to all customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to examine their inventory and hospital locations to identify the affected product; retrieve and return all affected products via Inter-Org Transfer and ship to Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, 07430; Attn: Regulatory Reporting, and attach the fluorescent orange PRODUCT REMEDIATION sticker and mark the outer box with the words "PRODUCT RECALL; complete and fax the attached Product Accountability Form and spreadsheet to (201) 831-6069 within 5 days of receipt of the notice.
If you have any questions, please contact the Manager, Divisional Regulatory Reporting at (201) 831-5970.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
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 surgeon may have difficulty inserting the pol yethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Action
An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool.
Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if
you have any questions regarding this action.
For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.