HOFFMANN 4935-0-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327294286), received between Dec 19, 2018 and Dec 19, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Slipped” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K163656, K233741); 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.

• InjuryDec 19, 2018Fracture; Device Slipped

  THIS PI IS FOR THE SECOND REVISION OF PATIENT'S FOOT ARCH, AND HEXAPOD STRUT ISSUE. AS REPORTED: "...WE REPLACE THAT FOOT ARCH WITH A NEW ONE AND HE[PATIENT] BREAKS THAT ONE THE FOLLOWING WEEK. BRING HIM BACK TO OFFICE AND REVISE. WHILE REVISING WE NOTICE THE PIN IN THE HEXAPOD STRUT WAS STARTING TO COME OUT". REP INDICATED PATIENT FACTOR: DIABETIC. REVISION, BROKEN FOOT ARCH, HEXAPOD STRUT MALFUNCTION.

  Patient problems: No Code Available

  MAUDE report 8182788 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163656, K233741. 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-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-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-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-3240-2018 · Jul 26, 2018 · Terminated
  Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002