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.
The cylindrical distal extensions were incorrectly coded and packaged.
Acción
Stryker Orthopaedics sent product recall letters to the Branch/Agency involved on 2/10/2004 via FedEx. International distributor was sent notification on 2/10/2004.
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.
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
Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo.
Acción
The firm initiated the recall via telephone on 03/01/2004 to all distributors followed up by recall letter on 03/05/2004.
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.
Notas adicionales en la data
Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
Causa
Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo.
Acción
The firm initiated the recall via telephone on 03/01/2004 to all distributors followed up by recall letter on 03/05/2004.
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.
Right ulna implants were etched and labeled as left ulna implants. left ulna implants may have been etched and labeled as right ulna implants.
Acción
Consignees were notified via e-mail on 3/16/04. Consignees were asked to secure their inventory from use and to notify all customers if they had further distributed the product. Product shipped to Japan and Singapore was contained prior to shipment to hospitals.
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.
Right ulna implants were etched and labeled as left ulna implants. left ulna implants may have been etched and labeled as right ulna implants.
Acción
Consignees were notified via e-mail on 3/16/04. Consignees were asked to secure their inventory from use and to notify all customers if they had further distributed the product. Product shipped to Japan and Singapore was contained prior to shipment to hospitals.
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
Rod, Fixation, Intramedullary And Accessories - Product Code HSB
Causa
One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation.
Acción
Units were distributed to twelve (12) consignees in the US and seven (7) foreign consignees (China, Japan, Korea, El Salvador, Singapore, Taiwan and UK)
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.
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
Tap, Bone - Product Code HWX
Causa
The recalled bone taps could break inside the vertebral body during the tapping process.
Acción
Recall letters, dated May 25, 2004, request that the consignees locate and return the 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.
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
Pin, Fixation, Smooth - Product Code HTY
Causa
Mislabeled as to size; 1.55 mm pins are labeled as 2mm.
Acción
Consignees were notified by recall letter dated July 7, 2004 and sent via fax.
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.
The firm received confirmed reports of genesis uni articular inserts not locking into tibial base plates intraoperatively.
Acción
Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email) on 06/21/2004 to request the return of any in stock product.
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 received confirmed reports of genesis uni articular inserts not locking into tibial base plates intraoperatively.
Acción
Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email) on 06/21/2004 to request the return of any in stock product.
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
To date, there has been one complaint reported. during a trinica surgical case, the surgeon was provided a standard disposable, trinica drill bit (part number 07.00166.001) for use with the trinica all through one drill guide instrumentation, instead of the all through one drill bit. this enabled the physician to drill a few millimeters further than expected.
Acción
The product distributed to accounts will be returned to Zimmer Spine. Product will be quarantined pending investigation and determination of appropriate corrective action.
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
The pouch containing the sterile product is not completely seal on all products. therefore , the sterility of the device is questionable.
Acción
Each consignee will be notified by telephone, email, letter or UPS overnight delivery. They will be asked to return the affected product to Linvatec, Largo, Florida for credit or no-cost replacement. A returned goods authorization number will be assigned for the returned product.
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.
On 8/20/04 the firm issued a letter, via certified return receipt. The letter warned of the potential for patient discomfort and burns. An addendum providing additional information regarding cable positioning was included with the letter.
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.