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Persona® 42-5891-059-04

by Zimmer, Inc.

Ref 42-5891-059-04

Persona® 42-5891-059-04 is a device classified as Class IIa in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-00889024558526), cleared under FDA 510(k) K191625 on 5 Sep 2019 (1 earlier submission) and listed in FDA GUDID since 4 Dec 2018 (UDI-DI 00889024558526), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191625

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00889024558526 Basic UDI-DI 00889024558526UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191625 Date5 Sep 2019DecidedStatusActive
United StatesGUDID listing GUDID Number00889024558526 UDI-DI Date4 Dec 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00889024558526 registered 30 Oct 2026 Active
  • FDA 510(k) K191625 decided 5 Sep 2019 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00889024558526 listed 4 Dec 2018 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2578-2026 FDA Class II initiated 11 May 2026

    Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

Timeline

5 dated events

  1. Cleared FDA 510(k) K181947
  2. Listed FDA GUDID 00889024558526
  3. Cleared FDA 510(k) K191625
  4. Recall initiated FDA recalls Z-2578-2026
  5. Registered EUDAMED B-00889024558526

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Persona®
Generic name
Knee tibia prosthesis trial, reusable
Device name
KN PSN REV TASP Shim
Model / Ref / Catalog
42-5891-059-04
Primary DI / UDI-DI
00889024558526
Basic UDI-DI
B-00889024558526
510(k) Number
FDA product code
MBH, OIY, JWH
EMDN code
L091104 Orthopaedic prostheses positioners, reusable
GMDN term
Knee tibia prosthesis trial, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3565, 888.3560
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Knee tibia prosthesis trial, reusable

Cleared under the same submission (K181947)

and 8 more cleared under K181947

Cleared under the same submission (K191625)

and 8 more cleared under K191625

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)