Reported Jun 13, 2018 · Terminated
TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM.…
Orthofix Srl
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthofix Srl · Via Delle Nazioni 9 · Bussolengo, N/A · N/A
Is this the product you have?
- TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile
- All Sizes120 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 includepost-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
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Barcodes Product as published 99-56-2200018054242512585120 MM, , Lot No. V1374370 (Lot No. laser marked on products V1369866, V1369865, V1369864), Exp. Date 06/08/2019, UDI 18054242512585 99-56-2202018054242512592140 MM, , Lot No. V1374298 (Lot No. laser marked on products V1369870, V1369868, V1369869, V1369872, V1369871), Exp. Date 06/07/2019, UDI 18054242512592 99-56-2204018054242512608160 MM, , 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 99-56-2206018054242512615180 MM, , 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 99-56-2208018054242512622200 MM, , Lot No. V1374361 (Lot No. laser marked on products V1369462, V1371128, V1371074, V1369463, V1370469), Exp. Date 06/08/2019, UDI 18054242512622 99-56-2210018054242512639220 MM, , Lot No. V1374373 (Lot No. laser marked on products V1369460, V1371250, V1371075), Exp. Date 06/08/2019, UDI 18054242512639 - Amount recalled
- 408 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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