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Prosthesis Head B 198-828/05

by WALDEMAR LINK GmbH & Co. KG

Ref 198-828/05Model Prosthesis head, uncemented, CoCrMo, 12/14 taper

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

CE MDR

Valid until

16 May 2029

CE MDR certificate

FDA recalls

5 ongoing

This device is named in the recall

Documents

1 certificate

Certifier DNV MEDCERT GmbH

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/MDR EUDAMED Number4026575-1-HSP-031001-W6 Basic UDI-DI 04026575133093UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575133093 UDI-DI Date24 Mar 2022ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13786GB450260609 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    9 Jun 2026
    Expires
    16 May 2029
    Reason
    Change approved

Recalls

5 recalls · 5 ongoing · FDA

    • Ongoing Z-2288-2025 FDA Class II initiated 15 Jul 2025

    Inconsistent size terminology and color coding used on labeling

  • 4 recalls, same reason

    • Ongoing Z-1299-2024 FDA Class II initiated 6 Feb 2024
    • Ongoing Z-1298-2024 FDA Class II initiated 6 Feb 2024
    • Ongoing Z-1297-2024 FDA Class II initiated 6 Feb 2024
    • Ongoing Z-1296-2024 FDA Class II initiated 6 Feb 2024

    Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

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  • Withdrawn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
Prosthesis Head B
Generic Name
Metallic femoral head prosthesis
Device Name
Prosthesis Heads B
Model / Ref / Catalog
198-828/05, Prosthesis head, uncemented, CoCrMo, 12/14 taper
Primary DI / UDI-DI
04026575133093
Basic UDI-DI
4026575-1-HSP-031001-W6
510(k) Number
FDA Product Code
JDG
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
EU market of registration
Germany
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: Metallic femoral head prosthesis

Cleared under the same submission (K953653)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • CMR Substance
  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (17)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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
  • Lot / Batch Number: No
  • Manufacturing Date: No