Skip to content

USTAR II Knee System

by United Orthopedic Corporation Taiwan EUDAMEDGUDID

Ref 9415-6000

Product code KWLEMDN L090402

Regulatory status

as of 25 Oct 2026

Recall ongoing. 4 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number471987216TD-Ir-003F4 Basic UDI-DIDate18 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04719872140498 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
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • 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 23 Oct 2026

Generic Name
Orthopaedic broach
Device Name
United Hip and Knee Non-sterile Reusable Instruments
Model / Reference
9415-6000
Primary DI / UDI-DI
04719872140498
Basic UDI-DI
471987216TD-Ir-003F4
Direct Marketing DI
04719872140498
510(k) Number
FDA Product Code
KWL, LWJ, LPH, KRO
EMDN Code
L090402 Orthopaedic surgery scalpels, reusable
GMDN Term
Orthopaedic broach
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3360, 888.3358, 888.3510
Market of Registration
France
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED 4aa91e53-f185-417c-8010-584114f312f6 61 fields · synced 23 Oct 2026
  • FDA UDI 060936a4-8e8e-40a4-b3dc-315543d13fa0 35 fields · synced 29 May 2026