Orthofix Srl: Medical Device Recall in 2018 - (Recall #: Z-2063-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 30, 2018

Date Posted: June 13, 2018

Recall Number: Z-2063-2018

Event ID: 80114

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.

Status: Terminated

Product Quantity: 408 units

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated