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 complaints regarding the incompatibility and dimensional interference between the double row footplates manufactured in a limited period of 2014 and struts manufactured after september 2016. the firm determined that certain batches of the double row footplates are not compatible with the current version of the tl-hex struts.
조치
Customers were notified on approximately January 30, 2018, via letter.
Instructions included to examine inventory for affected devices, remove any affected devices and arrange for the return of them, notify customers if the devices have been further distributed, and complete and return the response form. The notification also provided alternative procedures to complete the surgical intervention and treatment: 1) the surgeon can use parallel external support (either footplate or ring) that does not have dimensional issues; 2) the surgeon can complete fixation temporarily using non-hexapodal TrueLok connection elements, but the solution requires post-operative non-surgical intervention such as additional parallel external support that does not have dimensional issues or the surgeon completes the frame for treatment using TruLok non-hexapodal elements; 3) in case the issue arises in a strut changed during treatment, the surgeon can use an Emergency Tab Kit (see attached diagram in letter). For further questions, please call (214) 937-2000.
Worldwide Distribution - US Distribution within Texas., and to the countries of : Australia, Belgium, Chile, Denmark, France, Germany, Israel, Italy, Japan, South Africa, Spain, Sweden, Switzerland and United Kingdom.
제품 설명
TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. || The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device for stabilization and correction during the normal healing process. The purpose of the TL-HEX System is to provide a solution for deformity correction and keeping the bone segments aligned during the healing process. The device may only be applied by a physician, who is fully responsible for the surgical and post-operative procedures of the system and is able to manage possible mechanical and software limitations. Indications for use for adults and all pediatric subgroups except newborns include: post-traumatic joint contracture which has resulted in loss of range of motion, fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction, open and closed fracture fixation, pseudoarthrosis of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, correction of bony of soft tissue defects, joint arthrodesis, infected fractures or non unions.