Recall Z-2063-2018 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Orthofix Srl
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
| Date | Jan 30, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 408 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 Orthofix Srl, May 10, 2017 |