Juzo Soft 2081ATFFSH00 IIRecalls & reported problems

Julius Zorn, Inc. · 20-30 mmHg, Soft, Elastic Panty, FF,Short, Trend, II · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00640095246329), received between Jan 26, 2026 and Jan 26, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fracture1

Patient problems

Failure of Implant1
Inflammation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryJan 26, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE WITH PERIIMPLANTITIS. IMPLANT BROKEN IN THE MIDDLE, BOTH FRAGMENTS PRESENT.
Patient problems: Failure of Implant; Inflammation
MAUDE report 24185973 ↗

Device details

UDI-DI	`00640095246329`
Brand	Juzo Soft
Model	2081ATFFSH00 II
Catalog no.	24632
Company	Julius Zorn, Inc.
Product code	FQL · STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 18, 2023

Device type (GMDN): Compression/pressure sock/stocking, single-use

A garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a single-use device.

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All STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES) 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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