ACUFEX 72205104Recalls & reported problems

Smith & Nephew, Inc. · ACUFEX ACCESS ADVANCED POSITIONING KIT · Class 1

All models of ACUFEX (86)

Data updated Oct 16, 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 00885556714126), received between Dec 27, 2021 and Dec 27, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Delivered as Unsterile Product1

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 27, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT SUPPLY CHAIN IDENTIFIED THE ACUFEX ACCESS ADVANCED POSITIONING KIT THAT WAS NOT PROCESSED IN THE STANDARD MANNER; COMPROMISING THE STERILITY OF THE DEVICES CONTAINED IN THE BATCH. AT THIS TIME IT IS UNKNOWN IF THE DEVICE WAS USED ON THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13087731 ↗

Device details

UDI-DI	`00885556714126`
Brand	ACUFEX
Model	72205104
Company	Smith & Nephew, Inc.
Product code	KQZ · COMPONENT, TRACTION, NON-INVASIVE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 6, 2025

Device type (GMDN): Leg procedure positioner

A non-powered, patient-contact, preformed device (e.g., holder, sling, cushion, foam pad, wedge, multi-jointed structure) designed to be attached to an operating table to stabilize a patient's leg (e.g., thigh, knee, ankle) for adequate positioning and support of the body part during a medical/surgical procedure (e.g., orthopaedic surgery, examination, office procedure), or during patient transfer to an operating table; it is not intended for application of traction forces. It is typically padded to avoid damage of the skin/muscles/nerves, and components for attachment to the operating/examination table are typically included. This is a reusable device.

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All COMPONENT, TRACTION, NON-INVASIVE devices →

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 14, 2026 · each report above links to its original FDA record
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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