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Active Heel Traction Boot 72203272Recalls & reported problems

Smith & Nephew, Inc. · KIT AHTB RETRFIT HARDWARE UNIV HIP DISTR · Class 1

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010656346), received between Apr 9, 2019 and Mar 23, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 reports).

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

Device problems

  • Physical Resistance/Sticking2
  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 23, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE KIT AHTBB RETRFIT HARDWARE UNIVERSAL HIP DISTRACTOR WAS NOT MOVING. NO CASE INVOLVED THEREFORE THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11555958 ↗
  • MalfunctionNov 6, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE BALL JOINT OF THE KIT AHTB RETRFIT HARDWARE IS GETTING STUCK. NO CASE WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Patient Involvement

    MAUDE report 10804983 ↗
  • MalfunctionApr 9, 2019Detachment of Device or Device Component

    IT WAS REPORTED THAT THE BOOT SNAPPED OFF THE HOLDER DURING A HIP ARTHROSCOPY WHILE THE PATIENT WAS ON TRACTION. NO PATIENT INJURIES WERE REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. DELAY GREATER THAN 30 MINUTES WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8497620 ↗

Other APPARATUS, TRACTION, NON-POWERED devices

All APPARATUS, TRACTION, NON-POWERED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.