Active Heel Traction BootRecalls & reported problems across all models
Smith & Nephew, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 7 models of Active Heel Traction Boot by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2017 and Nov 3, 2025 — classified as 3 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Active Heel Traction Boot problems
Device problems
- Unintended Movement10
- Unstable8
- Break4
- Detachment of Device or Device Component4
- Physical Resistance/Sticking4
- Positioning Failure4
- Adverse Event Without Identified Device or Use Problem2
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Known Impact Or Consequence To Patient13
- No Patient Involvement6
- Abrasion1
Active Heel Traction Boot models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Active Heel Traction Boot 72203270APPARATUS, TRACTION, NON-POWERED20 reports
- Active Heel Traction Boot 72202682APPARATUS, TRACTION, NON-POWERED10 reports
- Active Heel Traction Boot 72203275APPARATUS, TRACTION, NON-POWERED4 reports
- Active Heel Traction Boot 72203345APPARATUS, TRACTION, NON-POWERED3 reports
- Active Heel Traction Boot 72204017APPARATUS, TRACTION, NON-POWERED3 reports
- Active Heel Traction Boot 72203272APPARATUS, TRACTION, NON-POWERED3 reports
- Active Heel Traction Boot 72204018COMPONENT, TRACTION, NON-INVASIVE1 report
Recent Active Heel Traction Boot adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, DURING THE EARLY PORTION OF THE PROCEDURE, THE TRACTION OF THE UNIVERSAL HIP DISTRACTOR WAS LOST. ATTEMPTS TO RE-TRACTION THE JOINT FAILED. UPON FURTHER INSPECTION, IT WAS NOTED THE CARRIAGE KNOB OF THE OPERATIVE SIDE MAST WAS BROKEN. SPECIFICALLY, A PIN SHEARED THAT ATTACHED THE KNOB TO THE BOLT THAT TIGHTENS THE DISTRACTOR BOOT ASSEMBLY TO THE MAST. THE PROCEDURE WAS COMPLETED WITH A SURGICAL GREATER THAN 30 MINUTES USING AN EQUIVALENT SN BACK-UP DEVICE. THERE WAS PROLONGED TIME UNDER ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23459989 ↗MalfunctionAug 12, 2025Break; Break
IT WAS REPORTED THAT WHILE PREPARING FOR A HIP ARTHROSCOPY, THE SCREW IN THE BLACK PLASTIC OF THE ACTIVE HEEL TRACTION BOOT SNAPPED, CAUSING THE PATIENT'S FOOT TO BE UNABLE TO BE SECURED, THE PATIENT HAD TO BE WOKEN UP FROM ANESTHESIA AND THE CASE POSTPONED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22782987 ↗MalfunctionJul 3, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT DURING A RIGHT HIP ARTHROSCOPY AND ACETABULAR LABRAL REPAIR, THE STRAPS OF THE ACTIVE HEEL TRACTION BOOT DID NOT WORK TO ADJUST, WITH GREATER DIFFICULTY THE STRAP THAT GOES ON THE ANKLE PART. WHEN DOING TRACTION, THE ANKLE STRAP CAME LOOSE, WHICH MADE THE SURGERY DIFFICULT AND THE DOCTOR WAS UNCOMFORTABLE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19666271 ↗InjuryNov 29, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Unintended Movement; Detachment of Device or Device Component; Device Dislodged or Dislocated; Unintended Movement
IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY SURGERY, THE BOLT OF THE UNKN ILIZAROV EXFIX INSTR DEVICE THAT CLAMPS THE TRACTION SLIDER IN POSITION, CAME APART AND WAS NOT ABLE TO TIGHTEN THE CLAMP SUFFICIENTLY. THE SURGEON USED A VICE GRIP TO RESOLVE THIS PROBLEM. ONCE THAT WAS FIXED, THE ORANGE STRAPS THAT HOLD THE FOOT INTO THE SUPPORT WERE SLIDING THROUGH THE CLASPS ALLOWING THE HEAL TO BE RAISED OUT OF THE SUPPORT. THEREFORE, THE PROCEDURE COULD NOT BE PERFORMED. THE PATIENT WAS ALREADY UNDER ANESTHESIA AND HAD TO BE WOKEN UP. THE PROCEDURE HAS BEEN POSTPONED. 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 15875767 ↗MalfunctionJul 12, 2021Break; Break
IT WAS REPORTED THAT, DURING THE HIP DISTRACTION PROCESS, THE METAL INNER SHEATH OF THE FINE TRACTION BROKE OFF INTO THE THREADS. IT WAS UNABLE TO PROVIDE TRACTION USING THE FINE TRACTION BLACK HANDLE. THERE WAS A BACKUP DEVICE AVAILABLE. A DELAY OF MORE THAN 30 MIN WAS REPORTED. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12155901 ↗MalfunctionMay 17, 2021Unstable; Unstable
IT WAS REPORTED THAT THE HIP DISTRACTOR DID NOT LOCK INTO THE PLACE, IT STILL MOVES. THE INCIDENT OCCURRED BEFORE THE PROCEDURE. THERE WAS NO DELAY AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS REPORTED. NO FURTHER DETAILS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11831531 ↗MalfunctionMay 6, 2021Unstable; Unstable
IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE, THE BALL AND SOCKET JOINT ON THE HIP DISTRACTOR WAS NOT HOLDING THE FOOT IN PLACE AND THEREFORE THE FOOT CONTINUOUSLY SLIPS OUT OF PLACE. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE REPORTED. 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 11782997 ↗MalfunctionApr 7, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT, DURING SURGERY, THE TRACTION IN THE "AHB UNIVERSAL HIP DISTRACTOR" WAS NOT WORKING CORRECTLY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE, BUT IT WAS HARDER THAN USUAL. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. 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 11628623 ↗MalfunctionMar 30, 2021Unintended Movement; Unintended Movement
IT WAS REPORTED THAT DURING SET UP OF HIP ARTHROSCOPY, THE ACTIVE HEEL TRACTION BOOT WOULD NOT STAY TIGHT ON CLAMPS. THE STRAPS KEPT SLIPPING THROUGH THE CLAMPS; THEREFORE, LOST ANY TRACTION APPLIED TO THE HIP. THE STRAPS APPEARED WORN. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO SIGNIFICANT DELAY WAS REPORTED. 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 11590348 ↗InjuryMar 30, 2021Unstable; Unstable
IT WAS REPORTED THAT DURING A HIP SCOPE, THE UNIVERSAL HIP DISTRACTOR WAS UNABLE TO LOCK, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE, THE LEG WAS LOCKED MANUALLY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 11587951 ↗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 ↗MalfunctionFeb 16, 2021Unstable; Material Twisted/Bent; Unstable; Material Twisted/Bent
IT WAS REPORTED THAT, THE HANDLE OF THE "AHTB UNIVERSAL HIP DISTRACTOR" WAS BENT, SO IT DID NOT STAY IN ONE POSITION. NO CASE REPORTED; 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 11333776 ↗MalfunctionFeb 9, 2021Unstable; Unstable
IT WAS REPORTED THAT DURING THE SET UP USING THE ACTIVE HEEL TRACTION BOOT, AS SOON AS THE DOCTOR PUT TRACTION ON THE PATIENT FOOT THE STRAP/BUCKLE OF THE CENTER STRAP ASSEMBLY CAME APART. HE ENSURED IT WAS CLIPPED IN AND STRAPPED PROPERLY BUT THE BUCKLES WERE NOT HOLDING TIGHTLY. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. 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 11305623 ↗MalfunctionFeb 3, 2021Unintended Movement; Unintended Movement
IT WAS REPORTED THAT ACTIVE HEEL TRACTION BOOT REPLACEMENT KIT WAS LOOSENING AND IT WAS NOT MAINTAINING TENSION ON THE BOOT CAUSING THE PATIENT´S FOOT TO SLIDE, ULTIMATELY IMPACTING DISTRACTION. THIS WAS NOTICED BEFORE THE PROCEDURE; THEREFORE, NO PATIENT WAS INVOLVED. A BACKUP DEVICE WAS AVAILABLE AND NO DELAY WAS REPORTED. 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 11273952 ↗MalfunctionFeb 3, 2021Unintended Movement; Unintended Movement
IT WAS REPORTED THAT ACTIVE HEEL TRACTION BOOT REPLACEMENT KIT WAS LOOSENING AND IT WAS NOT MAINTAINING TENSION ON THE BOOT CAUSING THE PATIENT´S FOOT TO SLIDE, ULTIMATELY IMPACTING DISTRACTION. THIS WAS NOTICED BEFORE THE PROCEDURE; THEREFORE, NO PATIENT WAS INVOLVED. A BACKUP DEVICE WAS AVAILABLE AND NO DELAY WAS REPORTED. 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 11273930 ↗
Other Smith & Nephew, Inc. products
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- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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