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Tibial Baseplate, PSA type 2203-5050

by United Orthopedic Corp. EUDAMEDGUDID

Active European Union Open recall

Ref 2203-5050

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04712602346122 Basic UDI-DIDate30 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04712602346122 UDI-DIDate24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Specification

EUDAMED · GUDID

Trade Name
U2 Total Knee System EUDAMED
Tibial Baseplate, PSA type GUDID
Generic Name
Cruciate-retaining total knee prosthesis
Device Name
U2 Total Knee System Tibial Baseplate, PSA, #5
Model / Ref / Catalog
2203-5050
Primary DI / UDI-DI
04712602346122
Basic UDI-DI
B-04712602346122
510(k) Number
FDA Product Code
JWH
EMDN Code
P090905020102 Revision knee prostheses fixed bearing tibial plates
GMDN Term
Cruciate-retaining total knee prosthesis
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3560
Market of Registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Posterior-stabilized total knee prosthesisCruciate-retaining total knee prosthesis

Cleared under the same submission (K082424)

Show all (12)

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