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Trinity Acetabular Hip System E321.228

by Corin Ltd

Ref E321.228Model Trinity Cobalt Chrome Modular Heads

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055196933750 Basic UDI-DI 05055196933750UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055196933750 UDI-DI Date17 Aug 2016ListedStatusListed 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

1 recall · FDA

    • Terminated Z-2604-2021 FDA Class II initiated 28 Jul 2021

    The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

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  • Withdrawn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
Trinity CoCr Modular Head Ø28mm Long +3.5mm 12/14 Eurocone Taper EUDAMED
Trinity Acetabular Hip System GUDID
Generic Name
Metallic femoral head prosthesis
Device Name
Trinity CoCr modular femoral heads for use in Trinity Acetabular System
Model / Ref / Catalog
E321.228, Trinity Cobalt Chrome Modular Heads
Primary DI / UDI-DI
05055196933750
Basic UDI-DI
B-05055196933750
510(k) Number
FDA Product Code
LWJ, LZO, MEH
EMDN Code
P090804050202 Metal femoral heads, total hip replacement
GMDN Term
Metallic femoral head prosthesis
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3360, 888.3353
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Metallic femoral head prosthesis

Cleared under the same submission (K093472)

Show all (12)

Other devices from Corin Ltd

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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