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USTAR II Hip System

by United Orthopedic Corporation Taiwan EUDAMEDGUDID

Ref 1115-3415

Product code KROEMDN P09080404

Regulatory status

as of 24 Oct 2026

Recall ongoing. 4 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04719872153993 Basic UDI-DIDate30 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04719872153993 UDI-DIDate24 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 Hip System EUDAMED
"UNITED" USTAR II Hip System GUDID
Generic Name
Metal-on-polyethylene total hip prosthesis
Device Name
USTAR II Hip System Press-Fit Straight Stem, RHS, Ti Plasma Spray, 15mm Dia., 200mm Stem Length
Model / Reference
1115-3415
Primary DI / UDI-DI
04719872153993
Basic UDI-DI
B-04719872153993
510(k) Number
FDA Product Code
KRO, LPH, LWJ, KWL
EMDN Code
P09080404 Large resections femoral stems
GMDN Term
Metal-on-polyethylene total hip 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

Other devices from United Orthopedic Corporation

See all devices from United Orthopedic Corporation →

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 af822443-55a2-4c2c-8b5e-517d33282a08 61 fields · synced 22 Oct 2026
  • FDA UDI a8d482f6-8fd1-4eaa-a954-5b9eef842314 35 fields · synced 30 May 2026