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.
Consignees were notified with a Product Recall Notice on 03/06/2009 that all screws must be checked to ensure that any discrepant products to be removed from the field.
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
Template - Product Code HWT
Cause
Oxford femoral drill guide lateral im adapter may have an undersized diameter that can cause an interference with pn: 32-422822, oxford microplasty im link.
Action
On 6/3/2015 an "URGENT MEDICAL DEVICE RECALL NOTICE" letter was sent to the affected distributors with instructions for locating and returning the affected product. The recall letter included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
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
Rod, fixation, intramedullary and accessories - Product Code HSB
Cause
A single distributed znn greater trochanter femoral nail may have been dented. potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture malunion or nonunion.
Action
On 6/17/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Managers with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761. Hours of operation are Monday through Friday, 8 a.m. through 5 p.m. EST.
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
Brace, drill - Product Code HXY
Cause
Musculoskeletal transplant foundation is recalling a certain lot of allofix insertion kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill.
Action
Musculoskeletal Transplant Foundation notified their affected customers of this recall by sending them a Voluntary Recall Notification Letter dated May 27, 2015 or via telephone. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 1-800-433-6576.
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
Screw, fixation, bone - Product Code HWC
Cause
Scfe drivers of the free-gliding scfe screw system are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation.
Action
Pega Medical sent an Urgent Field Safety-Recall letter via email on June 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Advise on action to be taken by the customer:
¿ Identify the device with the same catalogue number and lot number
¿ Return the device to Pega Medical Inc. to the address shown below using the FedEx account.
For further questions please call the firm at 450-688-5144 x. 242.
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
Pin, fixation, threaded - Product Code JDW
Cause
Musculoskeletal transplant foundation (mtf) is recalling one lot of mtf's allograft cortical pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin.
Action
Musculoskeletal Transplant Foundation initiated this recall by either telephoning their customers or by sending a recall letter dated 5/27/15 to the customer.
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
Rod, fixation, intramedullary and accessories - Product Code HSB
Cause
Recall for the aequalis im nail instrumentation set (tray number 9020000) due to several reports that the mast of the targeting jig (part number 9020060) is separating from the jig boom. separation will impact alignment and can affect the ability to fixate aequalis im nail screws.
Action
Consignees were sent on 6/25/2015 a Tornier "Urgent Medical Device Recall" letter dated June 24, 2015. The letter described the problem and the product affected by the recall. The letter provided information on jig inspection and referred consignee to the attached "Perfect Circles' surgical technique that should be used when separation is observed. Requested consignees to complete and return the questionnaire to FieldAction@tornier.com. For questions they can contact Customer Service Department at 1(888)494-7950.
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, ac-powered motor and accessory/attachment - Product Code HWE
Cause
Exp did not register as a medical device establishment, list the devices being recalled, or
establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Action
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014.
A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
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, based on matches of recall data from the U.S. and Finland.
Notes supplémentaires dans les données
Source: M2
Cause
Device failure / feature before use - material / component.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
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, based on matches of recall data from the U.S. and Finland.
Notes supplémentaires dans les données
Source: NCAR
Cause
Device failure / feature after commissioning - mechanical failure.