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USTAR II Knee System

by United Orthopedic Corporation 158 variants

Ref 2715-6414

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04711605588195 Basic UDI-DI 04711605588195UDI-DIDate10 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04711605588195 UDI-DI Date13 Feb 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

5 recalls · 4 ongoing · FDA

    • Ongoing Z-2884-2026 FDA Class II initiated 20 May 2026

    Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

  • 3 recalls, same reason

    • Ongoing Z-1216-2024 FDA Class II initiated 3 Jan 2024
    • Ongoing Z-1215-2024 FDA Class II initiated 3 Jan 2024
    • Ongoing Z-1217-2024 FDA Class II initiated 3 Jan 2024

    Their is a potential that the implant curved stem may be oriented incorrectly.

    • Terminated Z-0110-2022 FDA Class II initiated 27 Aug 2021

    Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Knee tibia prosthesis trial, reusable
Model / Reference
2715-6414
Primary DI / UDI-DI
04711605588195
Basic UDI-DI
B-04711605588195
510(k) Number
FDA Product Code
KRO, LPH, LWJ, KWL
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
Knee tibia prosthesis trial, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3510, 888.3358, 888.3360
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
TW-MF-000009523
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from United Orthopedic Corp.

See all devices from United Orthopedic Corp. →

Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No