U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
Causa
Complaints were recieved where swivels came out of plate and where the screw went through the plate.
Acción
The firm initiated the recall via telephone communication from sales representatives around August 2002.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
unknown device name - Product Code ---
Causa
Literature approved for international distribution only was distributed domestically.
Acción
The firm began to contact all US distributors on October 31, 2002, and all US sales representatives on November 1, 2002, by e-mail to initiate an examination of all Ascension MCP professional labeling in their stock, and request return of incorrect labeling. The firm additionally, initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request.
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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
unknown device name - Product Code ---
Causa
Brochures approved for international distribution only were distributed domestically.
Acción
The firm began to contact all US distributors on October 31, 2002 and all US sales representatives on November 1, 2002, by e-mail to inititate an examination of all pertinent professional labeling in their stock, and request return of incorrect labeling. The firm initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request.
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 HRX
Causa
Potential for non sterility as package tray does not contain aeration holes for eto processing.
Acción
Smith & Nephew notified customers by letter on 11/8/02. Users are requested to remove stock and return to Smith & Nephew.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Nail, Fixation, Bone, Metallic - Product Code NDH
Causa
The fixion interlocking proximal femoral hip pegs are defective due to possible tension failure.
Acción
The first letter, dated Monday October 14, 2002, went out to 10 of the firm''s agents who directly handled this line of product. The firm then sent out a follow-up letter, dated Wednesday December 11, 2002, to the same agents that they had previously made contact with to assure their knowledge regarding the recall.
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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
Causa
Cleaning agent residue from packaging material was adhering to implantable hip stems.
Acción
Consignees were notified on 12/26/2002 via telephone and e-mail.
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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
Causa
Cleaning agent residue from packaging material was adhering to implantable hip stems.
Acción
Consignees were notified on 12/26/2002 via telephone and e-mail.
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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
Causa
Cleaning agent residue from packaging material was adhering to implantable hip stems.
Acción
Consignees were notified on 12/26/2002 via telephone and e-mail.
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 and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
Notas adicionales en la data
Causa
Cleaning agent residue from packaging material was adhering to implantable hip stems.
Acción
Consignees were notified on 12/26/2002 via telephone and e-mail.
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.
Compression test results are not in accordance with device approval submission.
Acción
Products distributed to the U.S. market are being recalled via letter to users dated 1/6/2003, which was sent via certified mail. Customers are being asked to return product on hand to Zimmer.
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.
Compression test results are not in accordance with device approval submission.
Acción
Products distributed to the U.S. market are being recalled via letter to users dated 1/6/2003, which was sent via certified mail. Customers are being asked to return product on hand to Zimmer.
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.
Compression test results are not in accordance with device approval submission.
Acción
Products distributed to the U.S. market are being recalled via letter to users dated 1/6/2003, which was sent via certified mail. Customers are being asked to return product on hand to Zimmer.
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.
Some components have disassociated post-operatively resulting in additional surgery to the patient.
Acción
Notification letters were sent to Howmedica sales agents and Operating Room Supervisors via FedEx on 1/7/2003. On 2/12/2003, Howmedica again sent out notification letters on the extended recalled 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.
Some components have disassociated post-operatively resulting in additional surgery to the patient.
Acción
Notification letters were sent to Howmedica sales agents and Operating Room Supervisors via FedEx on 1/7/2003. On 2/12/2003, Howmedica again sent out notification letters on the extended recalled 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.
The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
Acción
Recall letters dated 1/7/03 were sent to each U.S. consignee via certified mail, requesting that they contact Zimmer for pick-up of the products if any was in stock. Ex-U.S. consignees were notified via e-mail.
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 femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
Acción
Recall letters dated 1/7/03 were sent to each U.S. consignee via certified mail, requesting that they contact Zimmer for pick-up of the products if any was in stock. Ex-U.S. consignees were notified via e-mail.
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 femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
Acción
Recall letters dated 1/7/03 were sent to each U.S. consignee via certified mail, requesting that they contact Zimmer for pick-up of the products if any was in stock. Ex-U.S. consignees were notified via e-mail.
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 femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
Acción
Recall letters dated 1/7/03 were sent to each U.S. consignee via certified mail, requesting that they contact Zimmer for pick-up of the products if any was in stock. Ex-U.S. consignees were notified via e-mail.