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U2 Total Knee System

by United Orthopedic Corporation 704 variants

Ref 2703-5232

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04712771481112 Basic UDI-DI 04712771481112UDI-DIDate30 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04712771481112 UDI-DI Date24 Oct 2015ListedStatusListed 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

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2883-2026 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.

    • Terminated Z-1129-2018 FDA Class II initiated 24 Nov 2017

    UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.

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  • Withdrawn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

Trade Name
U2 Total Knee System EUDAMED
Curved stem, PSA type, Cemented GUDID
Generic Name
Posterior-stabilized total knee prosthesis
Device Name
U2 Total Knee System Curved Stem, PSA, Cemented, 12mm Dia., 150mm Stem Length
Model / Ref / Catalog
2703-5232
Primary DI / UDI-DI
04712771481112
Basic UDI-DI
B-04712771481112
510(k) Number
FDA Product Code
JWH
EMDN Code
P0909800601, P0909800602
GMDN Term
Posterior-stabilized total knee prosthesis
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3560
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Length — 150 Millimeter

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 Corp.

See all devices from United Orthopedic Corp. →

Properties

  • 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