Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1 (REF 56-23080)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18054242512523), received between Jan 25, 2022 and Jan 25, 2022 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K170650); they may or may not involve this specific model.

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.

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.

• InjuryJan 25, 2022Break; Break

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: DATE OF INITIAL SURGERY: UNIDENTIFIED. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA AND FOOT. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: FEMALE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "ON (B)(6) - PATIENT CAME TO CLINIC WITH A BROKEN 3/8 HEX RING, AT THE POINT NEXT TO THE JOINT. PATIENT HAS BEEN DOING 15,000 STEPS A DAY SO SURGEON THINKS THIS IS WHAT IT COULD BE DOWN TO. ON (B)(6) - SAME PATIENT CAME TO CLINIC WITH BROKEN FOOTPLATE. FOOTPLATE WAS REMOVED AND PATIENT HAPPY." THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT; THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE; THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE; AN ADDITIONAL SURGERY WAS REQUIRED: NOT SURE BUT PROBABLY THE SAME WEEK TO PUT ON NEW RING (AFTER 3/8 BROKE); A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED: JUST ROUTINE CLINIC VISITS; COPY OF OPERATIVE REPORTS IS NOT AVAILABLE; COPY OF X-RAY IMAGES IS AVAILABLE; PATIENT'S CURRENT HEALTH CONDITION: FINE, SHOULD HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13341734 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170650. One submission often covers many models, so check the product and lot details in each record.

• Z-2063-2018 · Jan 30, 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. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of r