TRUE/LOK MONOLATERAL/BILATERAL FIXATOR 1 (REF 99-50-2203M)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18052469476437), received between Apr 30, 2026 and Apr 30, 2026 — 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 (K941048); 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.

• InjuryApr 30, 2026Break

  RECEIVED INFORMATION STATING THAT DURING AN ANKLE SURGERY TWO TORNADO HINGES BROKE. AS PER REPORTER, THEY WERE REPLACED WITH PHANTOM HINGES. THE SURGERY WAS PROLONGED BY 120 MINUTES. PATIENT WAS REPORTED TO BE IN A FINE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25040208 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K941048. One submission often covers many models, so check the product and lot details in each record.

• Z-0674-2008 · Sep 28, 2007 · Terminated
  Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following sizes: 75mm (Catalog Number: 50-1101), 100mm (Catalog Number: 50-1014), 150m