HOFFMANN 983031Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327297751), received between Jul 26, 2018 and Jul 26, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Application Program Problem” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K163656); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 26, 2018Improper or Incorrect Procedure or Method; Application Program Problem

  WHEN COMPUTING A CORRECTION PLAN WITH MORE THAN ONE CORRECTION PER DAY AND "CORRECT AXIAL FIRST" SELECTED, THE HOFFMANN LRF SOFTWARE ERRONEOUSLY COMPUTES THE AXIAL PORTION OF THE CORRECTION, RESULTING IN A CORRECTION PLAN THAT WOULD BE FASTER THAN INTENDED. THE SURGEON OVERRODE THE (ERRONEOUS) CORRECTION TIME WITH HIS OWN CALCULATIONS. WE PROVIDE A SURGEON OVERRIDE FEATURE IN CASE THEY WISH TO DO THAT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7723510 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163656. One submission often covers many models, so check the product and lot details in each record.

• Z-0291-2019 · Aug 28, 2018 · Terminated
  Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment
• Z-0288-2019 · Aug 28, 2018 · Terminated
  Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment
• Z-0289-2019 · Aug 28, 2018 · Terminated
  Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment
• Z-0290-2019 · Aug 28, 2018 · Terminated
  Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment
• Z-3240-2018 · Jul 26, 2018 · Terminated
  Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002