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SPII Model Lubinus 127-771/26

by WALDEMAR LINK GmbH & Co. KG

Ref 127-771/26Model Hip Stem, cemented, CoCrMo, XL neck, 126° CCD

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-003005-VZ Basic UDI-DI 04026575241569UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575241569 UDI-DI Date1 Nov 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 20399GB450240517 Active

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    17 May 2024
    Expires
    16 May 2029

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  • Withdrawn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
SPII Model Lubinus
Generic Name
Uncoated hip femur prosthesis, modular
Device Name
SPII Model Lubinus Hip Stem
Model / Ref / Catalog
127-771/26, Hip Stem, cemented, CoCrMo, XL neck, 126° CCD
Primary DI / UDI-DI
04026575241569
Basic UDI-DI
4026575-1-HSP-003005-VZ
510(k) Number
FDA Product Code
JDG
EMDN Code
P090804010102 Cemented femoral stems for primary implant, with fixed neck, anatomical
GMDN Term
Uncoated hip femur prosthesis, modular
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: Uncoated hip femur prosthesis, modular

Cleared under the same submission (K953653)

Show all (12)

Other devices from WALDEMAR LINK GmbH & Co. KG

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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