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PERSONA® Zimmer FuZion™ 42-5097-011-13

by Zimmer, Inc.

Ref 42-5181-005-12, 42-5181-005-08

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

2 closed

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/MDR EUDAMED Number889024E8HH Basic UDI-DI Date10 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00880304809888 UDI-DI Date31 Oct 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

2 recalls · FDA

    • Terminated Z-1238-2018 FDA Class II initiated 29 Nov 2017

    Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.

    • Terminated Z-0349-2018 FDA Class II initiated 5 Jul 2017

    Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Persona® EUDAMEDGUDID
PERSONA® Zimmer FuZion™ GUDID
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Knee tibia prosthesis trial, reusable
Device Name
Persona Partial Knee Tibial Bearing Trial
Model / Ref / Catalog
42-5181-005-12, 42-5181-005-08, 42-5097-011-13
Primary DI / UDI-DI
00880304809888, 00880304809840, 00889024232082
Basic UDI-DI
889024E8HH
510(k) Number
FDA Product Code
HWT, HSX
EMDN Code
L091104 Orthopaedic prostheses positioners, reusable
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Knee tibia prosthesis trial, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Class II GUDID
Regulation Number
888.4800, 888.3520
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I
Class II

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt YesGUDIDNoGUDID
  • Lot / Batch Number

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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No