NA BF538Recalls & reported problems
Steris Corporation · The Foot Traction Boot Pads with Straps, Adult is used with the TenZor Carbon Fiber Traction Unit Assembly. · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995165376), received between Dec 9, 2022 and Dec 9, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (1 report).
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
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2022Unintended Movement; Unintended Movement
THE USER FACILITY REPORTED THAT DURING A PROCEDURE A PATIENT'S FOOT FELL OUT OF THE TRACTION BOOT ASSEMBLY TO THEIR ORTHOPEDIC SURGICAL TABLE. THE PATIENT'S FOOT NEEDED TO BE REALIGNED IN THE BOOT ASSEMBLY CAUSING A PROCEDURE DELAY. NO REPORT OF INJURY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15949887 ↗
Other Apparatus, traction, non-powered devices
- Arthrex® AR-1600MArthrex, Inc. · Apparatus, traction, non-powered21 reports
- Active Heel Traction Boot 72203270Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED20 reports
- NA 357.371Synthes GmbH · APPARATUS, TRACTION, NON-POWERED16 reports
- NA SD393.640Synthes GmbH · APPARATUS, TRACTION, NON-POWERED15 reports
- NA 394.44Synthes GmbH · APPARATUS, TRACTION, NON-POWERED12 reports
- Active Heel Traction Boot 72202682Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED10 reports
- Arthrex® AR-8970JDArthrex, Inc. · Apparatus, traction, non-powered10 reports
- NA 72201725Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED8 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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