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
wheelchair - Product Code IOR
Causa
The wheelchairs with the travel ready option (trro) may contain incorrectly finished oval tie down brackets. the inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut.
Acción
The recalling firm notified their consignees in a letter dated 6/26/06.
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
wheelchair - Product Code IOR
Causa
The wheelchairs with the travel ready option (trro) may contain incorrectly finished oval tie down brackets. the inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut.
Acción
The recalling firm notified their consignees in a letter dated 6/26/06.
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
wheelchair - Product Code IOR
Causa
The wheelchairs with the travel ready option (trro) may contain incorrectly finished oval tie down brackets. the inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut.
Acción
The recalling firm notified their consignees in a letter dated 6/26/06.
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
wheelchair seat - Product Code ITI
Causa
Some of the wheelchairs were distributed with seats that did not have a seat positioning strap.
Acción
The recalling firm sent a recall letter, dated 06/06 to consignees.
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 company's initiation of the recall is based on a finding that some units of the total knee device may contain faulty pins based in the axis of the knee. small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function.
Acción
On 3/29/06 a press release was posted on OandP.com, an industry specific web site. An announcement listing involved serial numbers and contact phone numbers was also posted on the company''s web site, ossur.com. A two stage mailing has been constructed. The first letter sent to all customers March 30, 2006, describes the problem and models affected. The second letter, March 31, 2006, is customer specific and lists all of the involved serial numbers by model which were purchased by that customer. Telephone calls will be placed to customers who do not respond to the mailings.
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 company's initiation of the recall is based on a finding that some units of the total knee device may contain faulty pins based in the axis of the knee. small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function.
Acción
On 3/29/06 a press release was posted on OandP.com, an industry specific web site. An announcement listing involved serial numbers and contact phone numbers was also posted on the company''s web site, ossur.com. A two stage mailing has been constructed. The first letter sent to all customers March 30, 2006, describes the problem and models affected. The second letter, March 31, 2006, is customer specific and lists all of the involved serial numbers by model which were purchased by that customer. Telephone calls will be placed to customers who do not respond to the mailings.
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 company's initiation of the recall is based on a finding that some units of the total knee device may contain faulty pins based in the axis of the knee. small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function.
Acción
On 3/29/06 a press release was posted on OandP.com, an industry specific web site. An announcement listing involved serial numbers and contact phone numbers was also posted on the company''s web site, ossur.com. A two stage mailing has been constructed. The first letter sent to all customers March 30, 2006, describes the problem and models affected. The second letter, March 31, 2006, is customer specific and lists all of the involved serial numbers by model which were purchased by that customer. Telephone calls will be placed to customers who do not respond to the mailings.
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 company's initiation of the recall is based on a finding that some units of the total knee device may contain faulty pins based in the axis of the knee. small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function.
Acción
On 3/29/06 a press release was posted on OandP.com, an industry specific web site. An announcement listing involved serial numbers and contact phone numbers was also posted on the company''s web site, ossur.com. A two stage mailing has been constructed. The first letter sent to all customers March 30, 2006, describes the problem and models affected. The second letter, March 31, 2006, is customer specific and lists all of the involved serial numbers by model which were purchased by that customer. Telephone calls will be placed to customers who do not respond to the mailings.
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
Wood tables Plinth - Product Code INT
Causa
There have been reports of structural failure on the skirt of select tables. the risk to patients presented by possible structural failure of the skirt of the table is a slow collapse of the plinth which could cause the patient to be displaced.
Acción
Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
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
Wood tables Plinth - Product Code INT
Causa
There have been reports of structural failure on the skirt of select tables. the risk to patients presented by possible structural failure of the skirt of the table is a slow collapse of the plinth which could cause the patient to be displaced.
Acción
Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
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
Wood tables Plinth - Product Code INT
Causa
There have been reports of structural failure on the skirt of select tables. the risk to patients presented by possible structural failure of the skirt of the table is a slow collapse of the plinth which could cause the patient to be displaced.
Acción
Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
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
Wood tables Plinth - Product Code INT
Causa
There have been reports of structural failure on the skirt of select tables. the risk to patients presented by possible structural failure of the skirt of the table is a slow collapse of the plinth which could cause the patient to be displaced.
Acción
Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
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
Wood tables Plinth - Product Code INT
Causa
There have been reports of structural failure on the skirt of select tables. the risk to patients presented by possible structural failure of the skirt of the table is a slow collapse of the plinth which could cause the patient to be displaced.
Acción
Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
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
Vehicle, Motorized 3-Wheeled - Product Code INI
Causa
The throttle spring, located in the hand throttle assembly, can fracture, resulting in the scooter not stopping when the user releases the throttle.
Acción
The recalling firm sent field correction instructions to their customers on or about 11/1/05.
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
Vehicle, Motorized 3-Wheeled - Product Code INI
Causa
The throttle spring, located in the hand throttle assembly, can fracture, resulting in the scooter not stopping when the user releases the throttle.
Acción
The recalling firm sent field correction instructions to their customers on or about 11/1/05.
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
Bed, Patient Rotation, Powered - Product Code IKZ
Causa
To correct software issues in software versions 1.3 and 1.5 and to upgrade hatch latch handles to a more ergonomic design.
Acción
All KCI Service Centers notified via Technical Bulletin of upgrades. 1/24/2005
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
Wheelchair, Powered - Product Code ITI
Causa
While operating the powered wheelchair beyond a specified angle of recline, the wheelchair can travel at an unsafe speed when in this position.
Acción
On November 9, 2005, the firm contacted its consignees via telephone, which was followed up by a mailing, to alert them of the situation. The firm is making arrangements to conduct the service correction at users'' residence. All appointmens are scheduled to be completed by December 15, 2005.
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
Massager, Therapeutic, Electric - Product Code ISA
Causa
The massager may develop a crack in the cord insulation where it exits out of the strain relief. a crack in the insulation may expose live conductors resulting in a possible electric shock and injury to the user.
Acción
Wahl sent recall letters dated 10/31/05 to their direct accounts on 10/28/05, informing them of the potential for cracks in the power cord at the base of the unit resulting in possible electric shock and injury to the user. The accounts were requested to return all stocks of both massagers from their warehouse and retail store stock to Wahl for replacement of the white power cord with a black power cord from a different supplier. The accounts were also requested to supply Wahl with a list of customers who purchased these massagers after May 2003 so that they may be notified of the recall and have their massagers corrected. Wahl Clipper sent point of purchase ''Safety Recall Notice'' posters to the retail stores where these products were sold. The posters have guidance for consumers on returning their units and will be displayed for ninety (90) days. Wahl Clipper has posted the ''Safety Recall Notice'' on its website (www.wahl.com) with a toll-free telephone number (800-334-4627) for consumers to contact consumer service for guidance on returning their unit. The website notice will be displayed for ninety (90) days.
To the extent possible, Wahl Clipper will contact consumers directly to notify them of this repair recall to the extent that contact information is available.
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
Massager, Therapeutic, Electric - Product Code ISA
Causa
The massager may develop a crack in the cord insulation where it exits out of the strain relief. a crack in the insulation may expose live conductors resulting in a possible electric shock and injury to the user.
Acción
Wahl sent recall letters dated 10/31/05 to their direct accounts on 10/28/05, informing them of the potential for cracks in the power cord at the base of the unit resulting in possible electric shock and injury to the user. The accounts were requested to return all stocks of both massagers from their warehouse and retail store stock to Wahl for replacement of the white power cord with a black power cord from a different supplier. The accounts were also requested to supply Wahl with a list of customers who purchased these massagers after May 2003 so that they may be notified of the recall and have their massagers corrected. Wahl Clipper sent point of purchase ''Safety Recall Notice'' posters to the retail stores where these products were sold. The posters have guidance for consumers on returning their units and will be displayed for ninety (90) days. Wahl Clipper has posted the ''Safety Recall Notice'' on its website (www.wahl.com) with a toll-free telephone number (800-334-4627) for consumers to contact consumer service for guidance on returning their unit. The website notice will be displayed for ninety (90) days.
To the extent possible, Wahl Clipper will contact consumers directly to notify them of this repair recall to the extent that contact information is available.
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
Wheelchair, Powered - Product Code ITI
Causa
The engager set screw may become loose. this problem may cause the potentiometer to become off-center thus affecting the end users stopping capabilities.
Acción
The firm sent out letters to their customers on 4/20/2005. The firm's sales representatives were also notified on 4/20/2005.
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
Wheelchair, Powered - Product Code ITI
Causa
If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. this failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury.
Acción
The recalling firm contacted all consignees by phone between May 9 and May 25, 2005 and sent an urgent field correction needed letter, dated April, 2005 to all consignees.
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
Wheelchair, Powered - Product Code ITI
Causa
If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. this failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury.
Acción
The recalling firm contacted all consignees by phone between May 9 and May 25, 2005 and sent an urgent field correction needed letter, dated April, 2005 to all consignees.
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
Wheelchair, Powered - Product Code ITI
Causa
If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. this failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury.
Acción
The recalling firm contacted all consignees by phone between May 9 and May 25, 2005 and sent an urgent field correction needed letter, dated April, 2005 to all consignees.
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
Wheelchair, Mechanical - Product Code IOR
Causa
The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
Acción
Cypress Medical telephoned McKesson on 5/3/04, informing them of the problem with the rivet screw collar and requesting them to place the wheelchairs on hold in their distribution warehouses, pending inspection and tightening of the rivet screws to properly seat the rivet crew collar into the frame. Cypress also called all direct accounts in June and July 2004, and known end users in January 2005. Voluntary Field Correction letters dated 3/3/05 are being sent to those end users who could not be reached by telephone.