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U.S. Department of Health and Human Services

Class 2 Device Recall Double Row Footplates (TLHEX Sterile; All sizes)

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  Class 2 Device Recall Double Row Footplates (TLHEX Sterile; All sizes) see related information
Date Initiated by Firm January 30, 2018
Create Date June 05, 2018
Recall Status1 Terminated 3 on May 13, 2021
Recall Number Z-2063-2018
Recall Event ID 80114
510(K)Number K170650  
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
Product 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.
Code Information a) 120 MM, Product Code 99-56-22000, Lot No. V1374370 (Lot No. laser marked on products V1369866, V1369865, V1369864), Exp. Date 06/08/2019, UDI 18054242512585;   b) 140 MM, Product Code 99-56-22020, Lot No. V1374298 (Lot No. laser marked on products V1369870, V1369868, V1369869, V1369872, V1369871), Exp. Date 06/07/2019, UDI 18054242512592;   c) 160 MM, Product Code 99-56-22040, Lot No. V1374255 (Lot No. laser marked on products V1370134, V1370136, V1370128, V1370133, V1370132, V1370131), Exp. Date 06/07/2019, Lot No. V1374374 (Lot No. laser marked on products V1370130), Exp. Date 06/08/2019, Lot No. R1065030 (Lot No. laser marked on products V1370134, V1370136, V1370128, V1370133, V1370132, V1370131), Exp. Date 12/16/2021, UDI 18054242512608;   d) 180 MM, Product Code 99-56-22060, Lot No. V1374259 (Lot No. laser marked on products V1370581, V1369468, V1369469, V1369467, V1369466, V1369465, V1369471, V1369470, V1370597), Exp. Date 06/07/2019, UDI 18054242512615;   e) 200 MM, Product Code 99-56-22080, Lot No. V1374361 (Lot No. laser marked on products V1369462, V1371128, V1371074, V1369463, V1370469), Exp. Date 06/08/2019, UDI 18054242512622;   f) 220 MM, Product Code 99-56-22100, Lot No. V1374373 (Lot No. laser marked on products V1369460, V1371250, V1371075), Exp. Date 06/08/2019, UDI 18054242512639
Recalling Firm/
Orthofix Srl
Via Delle Nazioni 9
Bussolengo Italy
For Additional Information Contact US Agent
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KTT and Original Applicant = Orthofix Srl