Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1 (REF 56-20040)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18054242510703), received between Nov 13, 2019 and Nov 13, 2019 — classified as 1 injury.

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

• InjuryNov 13, 2019Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 54-1216 (TL, WIRES, BAYONET, 1.8MM X 400MM). BATCH NUMBER: UNKNOWN. QUANTITY: 2 (MFR REPORTS 9680825-2019-00063 AND 9680825-2019-00064). HOSPITAL NAME: (B)(6) GENERAL HOSPITAL. SURGEON'S NAME: MR (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: FEMALE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "THIS COMPLAINT IS FOR A FEMALE PATIENT WHO HAS HAD 2 WIRES BREAK ON HER FRAME WHICH WAS FIRST PUT ON (B)(6) 2019. THE PATIENT HAD TO GO BACK TO CLINIC TO HAVE THE WIRE REMOVED AND THEN A FOLLOW UP OPERATION TO HAVE A NEW WIRE PUT ON OTHERWISE THERE WOULD BE A LOOSE OF SUPPORT." THE COMPLAINT REPORT FORM ALSO INDICATED: THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS REQUIRED: "DATE (B)(6) 2019 AND (B)(6) 2019". A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED: "DATE (B)(6) 2019 AND (B)(6) 2019".

  Patient problems: No Code Available

  MAUDE report 9315177 ↗

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