Dynex DF-AS191-303Recalls & reported problems

Vilex LLC · Dynex Speed Strut Large 191-303mm · Class 2 · Implant

Data updated Oct 18, 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 00841731129857), received between Feb 10, 2026 and Feb 10, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Detachment of Device or Device Component1

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

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

MalfunctionFeb 10, 2026Detachment of Device or Device Component
REPORTED DYNEX SPEED STRUT FAILURE. DISTAL ENDS SHEARED OFF WHEN ENGAGED WITH THE ROUND PORTION OF THE STRUT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24306390 ↗

Device details

UDI-DI	`00841731129857`
Brand	Dynex
Model	DF-AS191-303
Company	Vilex LLC
Product code	KTT · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Class	Class 2
FDA submission	K202054
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 2, 2022

Device type (GMDN): External orthopaedic fixation system, single-use

An assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.

Other Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component devices

PRECICE® Plating System LP4.5-DLF31
Nuvasive Specialized Orthopedics, Inc. · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
3 recalls0 reports
R3 71364451
Smith & Nephew, Inc. · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
145 reports
DFS HA BONE SCREWS HAA60-15020
Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 recalls0 reports
DFS HA BONE SCREWS HAA60-11030
Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 recalls0 reports
DFS HA BONE SCREWS HAB60-12040
Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 recalls0 reports
DFS HA BONE SCREWS HAA60-13040
Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 recalls0 reports
DFS HA BONE SCREWS HAA60-18030
Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 recalls0 reports
DFS HA BONE SCREWS HAA60-15030
Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 recalls0 reports

All Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 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.

How reports and recalls are matched · Editorial policy · Report an error on this page