Odyssey K3 ODK3 EN 26 D2Recalls & reported problems

College Park Industries, Inc. · Odyssey K3 Foot, Endo IP, 26cm, Category 2 · 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 00195411041428), received between May 9, 2024 and May 9, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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

Mechanical Problem1
No Apparent Adverse Event1

Patient problems

Bone Fracture(s)1
Hip Fracture1

Recent adverse event reports

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

InjuryMay 9, 2024Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event
PATIENT FELL A FEW MONTHS AGO AND WAS HOSPITALIZED FOR A BROKEN HIP AND WAS NOT ABLE TO COME IN TO SEE HIS PROSTHETIST DUE TO HIS INJURY. THE PATIENT IS AN ABOVE KNEE AMPUTEE AND ALSO WEARS A PROSTHETIC MICROPROCESSOR KNEE (THIS PRODUCT IS NOT MANUFACTURED BY COLLEGE PARK). THE PROSTHETIST COULD NOT CONFIRM IF THE ODYSSEY K3 PROSTHETIC FOOT OR PROSTHETIC MICROPROCESSOR KNEE CONTRIBUTED TO THE FALL. THE PROSTHETIST DID MENTION THAT THE ODYSSEY K3 PROSTHETIC FOOT DID NOT FEEL SMOOTH IN MOTION. COLLEGE PARK WANTED TO REPORT THE INCIDENT SINCE THE FALL CAUSED THE PATIENT TO HAVE SURGERY. THE ODYSSEY K3 FOOT HAS A 3 YEAR WARRANTY AND THIS PRODUCT IS ONE MONTH FROM BEING OUT OF WARRANTY.
Patient problems: Bone Fracture(s); Hip Fracture
MAUDE report 19279293 ↗

Device details

UDI-DI	`00195411041428`
Brand	Odyssey K3
Model	ODK3 EN 26 D2
Company	College Park Industries, Inc.
Product code	ISH · Component, External, Limb, Ankle/Foot
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 26, 2023

Device type (GMDN): Hydraulic/pneumatic external ankle-foot prosthesis

A device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent foot and/or ankle, wherein the principle of operation for dorsiflexion/plantar flexion motion control is based on hydraulics and/or pneumatics (e.g., using fixed fluid orifices, or needle or servo valves). It responds to changes in motion by providing variable damping through progressive adjustments [i.e. over several steps] in motion resistance. It may have various designs and functional features (e.g., integrated carbon fibre blade, split/sandal toe, adjustable heel height) for support during a variety of activities.

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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