Orthofix TrueLok Hexapod System (TL-HEX) V2.0Recalls & reported problems across all models

We found 15 models of Orthofix TrueLok Hexapod System (TL-HEX) V2.0 by Orthofix Srl in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Dec 16, 2016 and Oct 22, 2025 — classified as 37 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (32 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Orthofix TrueLok Hexapod System (TL-HEX) V2.0 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 6 of these models · Recall details · FDA record ↗

Most reported Orthofix TrueLok Hexapod System (TL-HEX) V2.0 problems

Orthofix TrueLok Hexapod System (TL-HEX) V2.0 models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1

  Software For Diagnosis/Treatment
  1 recall3 reports
• Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1

  Software For Diagnosis/Treatment
  1 recall1 report
• Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1

  Software For Diagnosis/Treatment
  1 recall0 reports
• Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1

  Software For Diagnosis/Treatment
  1 recall0 reports
• Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1

  Software For Diagnosis/Treatment
  1 recall0 reports
• Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1

  Software For Diagnosis/Treatment
  1 recall0 reports
• Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1

  Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
  14 reports
• Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1

  Software for diagnosis/treatment
  9 reports
• Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1

  Software for diagnosis/treatment
  7 reports
• Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1

  Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
  4 reports
• Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1

  Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
  3 reports
• Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1

  Software for diagnosis/treatment
  1 report
• Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1

  Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
  1 report
• Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1

  Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
  1 report
• Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1

  Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
  1 report

Recent Orthofix TrueLok Hexapod System (TL-HEX) V2.0 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGICAL PROCEDURE TWO STRUTS DISASSEMBLED FROM THE FRAME AND COULD NOT BE RECONNECTED. THE SURGICAL PROCEDURE WAS COMPLETED USING REPLACEMENT DEVICES IMMEDIATELY AVAILABLE. AS PER REPORTED, THIS CAUSED A DELAY OF 30-45 MINUTES, NO ADVERSE EFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358042 ↗
• MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGICAL PROCEDURE TWO STRUTS DISASSEMBLED FROM THE FRAME AND COULD NOT BE RECONNECTED. THE SURGICAL PROCEDURE WAS COMPLETED USING REPLACEMENT DEVICES IMMEDIATELY AVAILABLE. AS PER REPORTED, THIS CAUSED A DELAY OF 30-45 MINUTES, NO ADVERSE EFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357948 ↗
• MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGICAL PROCEDURE TWO STRUTS DISASSEMBLED FROM THE FRAME AND COULD NOT BE RECONNECTED. THE SURGICAL PROCEDURE WAS COMPLETED USING REPLACEMENT DEVICES IMMEDIATELY AVAILABLE. AS PER REPORTER, THIS CAUSED A DELAY OF 30-45 MINUTES, NO ADVERSE EFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336392 ↗
• MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGICAL PROCEDURE TWO STRUTS DISASSEMBLED FROM THE FRAME AND COULD NOT BE RECONNECTED. THE SURGICAL PROCEDURE WAS COMPLETED USING REPLACEMENT DEVICES IMMEDIATELY AVAILABLE. AS PER REPORTER, THIS CAUSED A DELAY OF 30-45 MINUTES, NO ADVERSE EFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336391 ↗
• MalfunctionOct 7, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  RECEIVED INFORMATION STATING THAT DURING TREATMENT FOUR (4) STRUTS WERE REPORTED AS FAULTY. PATIENT UNDERWENT A REVISION PROCEDURE. AS PER THE REPORTER THE PATIENT WAS DISCHARGED AND IS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture

  MAUDE report 23232599 ↗
• MalfunctionOct 7, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  RECEIVED INFORMATION STATING THAT DURING TREATMENT FOUR (4) STRUTS WERE REPORTED AS FAULTY. PATIENT UNDERWENT A REVISION PROCEDURE. AS PER THE REPORTER THE PATIENT WAS DISCHARGED AND IS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture

  MAUDE report 23232583 ↗
• MalfunctionOct 7, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  RECEIVED INFORMATION STATING THAT DURING TREATMENT FOUR (4) STRUTS WERE REPORTED AS FAULTY. PATIENT UNDERWENT A REVISION PROCEDURE. AS PER THE REPORTER THE PATIENT WAS DISCHARGED AND IS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture

  MAUDE report 23232569 ↗
• MalfunctionOct 7, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  RECEIVED INFORMATION STATING THAT DURING TREATMENT FOUR (4) STRUTS WERE REPORTED AS FAULTY. PATIENT UNDERWENT A REVISION PROCEDURE. AS PER THE REPORTER THE PATIENT WAS DISCHARGED AND IS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture

  MAUDE report 23232558 ↗
• 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 ↗
• InjuryMay 31, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: 49 YEAR-OLD, MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: CONSTRUCT STRUTS BROKE DURING THE CONSTRUCTION OF THE FRAME, ALL STRUTS WHERE STILL LOOSE WITH NO TENSION APPLIED WHEN THEY DISMANTLED. TWO STUD BALL JOINTS PULLED OUT OF THE SOCKET. THE MALE SIDE OF THE STRUTS CAME UNDONE. PATIENT WOULD HAVE RECEIVED A STACK FRAME WITH 6 HEX STRUTS ON THE ONE RING BLOCK AND 4 RAPID ADJUST STRUTS ON THE SECOND RING BLOCK. THE FRAME THEN HAD TO BE CHANGED FROM A 4 RAPID ADJUST STRUT RING BLOCK TO A 6 HEX STRUT RING BLOCK. MALE SIDE CAME UNDONE. 50% OF THE FRAME WAS ALREADY WITH HEX STRUTS BUT DUE TO FAILURE OF THE RAPID ADJUST STUTS THE FRAM HAD TO BE CONVERTED TO 100% HEX FRAME. THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. - THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. - A REPLACEMENT DEVICE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907216 ↗
• InjuryMay 31, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR(B)(6). DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: 49 YEAR-OLD, MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: CONSTRUCT STRUTS BROKE DURING THE CONSTRUCTION OF THE FRAME, ALL STRUTS WHERE STILL LOOSE WITH NO TENSION APPLIED WHEN THEY DISMANTLED. TWO STUD BALL JOINTS PULLED OUT OF THE SOCKET. THE MALE SIDE OF THE STRUTS CAME UNDONE. PATIENT WOULD HAVE RECEIVED A STACK FRAME WITH 6 HEX STRUTS ON THE ONE RING BLOCK AND 4 RAPID ADJUST STRUTS ON THE SECOND RING BLOCK. THE FRAME THEN HAD TO BE CHANGED FROM A 4 RAPID ADJUST STRUT RING BLOCK TO A 6 HEX STRUT RING BLOCK. MALE SIDE CAME UNDONE. 50% OF THE FRAME WAS ALREADY WITH HEX STRUTS BUT DUE TO FAILURE OF THE RAPID ADJUST STUTS THE FRAM HAD TO BE CONVERTED TO 100% HEX FRAME. THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT; - THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE; - A REPLACEMENT DEVICE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907215 ↗
• InjuryMay 25, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 50-10300 (MEDIUM STRUT TL-HEX - 114MM-184MM) AND 50-10400 ((LONG STRUT TL-HEX - 158MM-318MM). BATCH NUMBER: B1452665 (CODE 50-10300) AND B1405090 (CODE 50-10400) AND B1406264 (CODE 50-10400). QUANTITY: 3 (MFR REPORTS 9680825-2021-00044 AND 9680825-2021-00046). PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "THROUGHOUT THE COURSE OF THE HEX PROGRAMME, 3 X MOUNTING CAPS DISLODGED RESULTING IN THE MOUNTING STUDS LOSING LOCKING ABILITY BETWEEN THE RING AND THE HEX STRUTS. FRAME INSTABILITY HAS EXPERIENCED". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF ACHIEVED CORRECTION). 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 NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITION: FRACTURE REDUCED AND ALIGNMENT ACQUIRED. MANUFA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11874916 ↗
• InjuryMay 25, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 50-10300 (MEDIUM STRUT TL-HEX - 114MM-184MM) AND 50-10400 ((LONG STRUT TL-HEX - 158MM-318MM). BATCH NUMBER: B1452665 (CODE 50-10300) AND B1405090 (CODE 50-10400) AND B1406264 (CODE 50-10400). QUANTITY: 3 (MFR REPORTS 9680825-2021-00044 AND 9680825-2021-00045). PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "THROUGHOUT THE COURSE OF THE HEX PROGRAMME, 3 X MOUNTING CAPS DISLODGED RESULTING IN THE MOUNTING STUDS LOSING LOCKING ABILITY BETWEEN THE RING AND THE HEX STRUTS. FRAME INSTABILITY HAS EXPERIENCED." THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF ACHIEVED CORRECTION). 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 NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITION: FRACTURE REDUCED AND ALIGNMENT ACQUIRED. MANUFA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11874915 ↗
• InjuryMay 25, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 50-10300 (MEDIUM STRUT TL-HEX - 114MM-184MM) AND 50-10400 ((LONG STRUT TL-HEX - 158MM-318MM) BATCH NUMBER: B1452665 (CODE 50-10300) AND B1405090 (CODE 50-10400) AND B1406264 (CODE 50-10400) QUANTITY: 3 (MFR REPORTS 9680825-2021-00045 AND 9680825-2021-00046). PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "THROUGHOUT THE COURSE OF THE HEX PROGRAMME, 3 X MOUNTING CAPS DISLODGED RESULTING IN THE MOUNTING STUDS LOSING LOCKING ABILITY BETWEEN THE RING AND THE HEX STRUTS. FRAME INSTABILITY HAS EXPERIENCED. ". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF ACHIEVED CORRECTION). 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 NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITION: FRACTURE REDUCED AND ALIGNMENT ACQUIRED. MANUFA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11874908 ↗
• InjuryMay 20, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: 50-10300 (MEDIUM STRUT TL-HEX - 114MM-184MM ) - BATCH NUMBER: B1445646 - QUANTITY: (B)(4) (MFR REPORTS 9680825-2021-00041 AND 9680825-2021-00042 AND 9680825-2021-00043) - SURGERY DESCRIPTION: FRACTURE TREATMENT - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM - EVENT DESCRIPTION: "PRODUCT FAILED DURING CORRECTION OF HEX RING PROGRAM. 3 STRUTS FAILED ON RING". THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF ACHIEVED CORRECTION) - 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 NOT REQUIRED - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED - COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE - PRODUCT IS AVAILABLE FOR RETURN FURTHER INFORMATION RECEIVED ON MAY 24, 2021 FROM THE LOCAL DISTRIBUTOR: - DATE OF INITIAL SURGERY : (B)(6) 2020 - DATE OF THE DEVICE'S FAILURE: DURING (B)(6) 2021 TO (B)(6) 2021 - ANATOMICAL SITE: ANKLE - PATIENT INFORMATION (AGE,

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11853739 ↗

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