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USTAR II Knee System

by United Orthopedic Corporation Taiwan EUDAMEDGUDID

Ref 2515-1113

Product code KROEMDN P090906

Regulatory status

as of 24 Oct 2026

Recall ongoing. 4 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04719872154365 Basic UDI-DIDate30 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04719872154365 UDI-DIDate21 Feb 2020ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

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.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
USTAR II Knee System EUDAMED
"UNITED" USTAR II Knee System GUDID
Generic Name
Rotating hinged total knee prosthesis
Device Name
USTAR II Knee System Cemented Curved Stem, RHS, Ti Plasma Spray, 13mm Dia., 125mm Stem Length
Model / Reference
2515-1113
Primary DI / UDI-DI
04719872154365
Basic UDI-DI
B-04719872154365
510(k) Number
FDA Product Code
KRO, LPH, LWJ, KWL
EMDN Code
P090906 Knee prostheses for large resections
GMDN Term
Rotating hinged total knee prosthesis
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3510, 888.3358, 888.3360
Market of Registration
France
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

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

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (18)
  • Reusable: 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
  • Manufacturing Date: No

Sources (2)

  • EUDAMED 49cfdbe1-e7ea-4029-8a72-7460f25e8bf0 61 fields · synced 22 Oct 2026
  • FDA UDI 56c3dabd-701a-4358-9ae7-7073cd48f93a 35 fields · synced 30 May 2026