Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1 (REF 54-11230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18033509858222), received between May 8, 2019 and May 8, 2019 — 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.

• InjuryMay 8, 2019Break

  INFORMATION PROVIDED STATES THAT APPX. 2 1/2 WEEKS POST OP THE PATIENT WAS WEIGHT BEARING WITH A ROCKER RAIL ATTACHED TO THE FRAME. TWO OF THE THREE HALF PINS THAT WERE APPLIED SHEARED. THE 5MM HALF PIN BROKE 1/2 CM FROM THE FIXATION BOLT AND WAS REMOVED. THE 4MM HALF PIN BROKE AT THE SKIN AND WAS LEFT IN THE PATIENT. THE FRAME REMAINS ON THE PATIENT AND WILL BE REMOVED AFTER COMPLETION OF TREATMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8593735 ↗

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