Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1 (REF 99-56-22040)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18054242512608), received between Dec 13, 2017 and Dec 13, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 30, 2018Class IITerminated

   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.

   Z-2063-2018 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2017Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6) - SURGEON'S NAME: (B)(6) - DATE OF INITIAL SURGERY: (B)(6) 2017 - BODY PART TO WHICH DEVICE WAS APPLIED: FOOT - SURGERY DESCRIPTION: NA - PATIENT INFORMATION: FEMALE - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM - EVENT DESCRIPTION: "DURING THE SURGERY, (B)(6) DECIDE TO PUT A DOUBLE FOOT PLATE RING TO FINISH THE FRAME HE MADE ON THE TIBIA. HE PUT ALL THE WIRE, TENSE THEM, CUT THEM, AND WHEN HE START TO PUT THE STRUT INTO THE HOLE, NOT A SINGLE HOLE FIT. THE HOLES WHERE TO TIGHT. SO INSTEAD OF USING STRUT, HE USE TREATHED RODS. THE DEVICE HAS ADVERSE EFFECTS ON PATIENT. NOT IMMEDIATELY. BUT THE FRAME WAS NOT CONCLUSIVE AND MOVE DURING THE CORRECTION, SO (B)(6) NEEDS TO CHANGE ALL THE FRAME NEXT MONTH ((B)(6)) AND DO IT AGAIN AND THE DEFECT DEVICE IS PART OF THE PROBLEM". THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT -LOSS OF DISTRACTION/CORRECTION ACHIEVED. THE SURGEON HAD TO USE THREADED ROD TO FINISH THE FRAME INSTEAD OF HEXAPODAL STRUTS. THE CORRECTION IS NOT CONCLUSIVE. HE NEEDS TO TA

  Patient problems: No Code Available

  MAUDE report 7112767 ↗