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SPII Model Lubinus Hip Stem - Instruments 131-420/26

by WALDEMAR LINK GmbH & Co. KG

Ref 99-2769/26, 127-913/26, 127-713/26, 127-764/26Model Hip stem, cemented, CoCrMo, XL polished neck, 126° CCD, Hip stem, cemented, CoCrMo, long stem prosthesis, standard neck, 126° CCD, Hip stem, cemented, CoCrMo, standard neck, CCD 126°, 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-HSP-003009-WD Basic UDI-DI Date7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575241439 UDI-DI Date19 Dec 2022ListedStatusListed 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  • Withdrawn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 Hip Stem - Instruments
SPII Model Lubinus
Generic Name
Surgical implant template, reusable
Uncoated hip femur prosthesis, modular
Revision uncoated hip femur prosthesis
Model / Ref / Catalog
127-764/26, 127-713/26, 127-913/26, Hip stem, cemented, CoCrMo, XL polished neck, 126° CCD, 99-2769/26, long stem prosthesis, standard neck, CCD 126°, XL neck, 131-420/26
Primary DI / UDI-DI
04026575241439, 04026575024056, 04026575024964, 04026575410309, 04026575385904
Basic UDI-DI
4026575-1-HSP-003009-WD, 4026575-1-HSP-003010-VP, 4026575-1-HSP-003002-VQ, 4026575-1-HSP-003005-VZ
510(k) Number
FDA Product Code
HWT, JDG
EMDN Code
P090804010102, P090804030101
GMDN Term
Surgical implant template, reusable
Uncoated hip femur prosthesis, modular
Revision uncoated hip femur prosthesis
Device Class
Class III EUDAMED
Class I GUDID
Class II GUDID
Regulation Number
888.4800, 888.3360
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class I
Class II
SterileEUDAMED
Yes
GUDID
Yes
No
ImplantableEUDAMED
Yes
GUDID
Yes
No

Related devices

Category: Surgical implant template, reusable

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Properties

  • Sterile YesEUDAMEDGUDIDNoGUDID
  • Single Use NoGUDIDYesGUDID
  • Implantable YesEUDAMEDGUDIDNoGUDID
  • CMR Substance
  • Prescription Use
  • Premarket Exempt YesGUDIDNoGUDID
  • Lot / Batch Number YesGUDIDNoGUDID
  • Serial Number NoGUDIDYesGUDID
  • Expiration Date NoGUDIDYesGUDID
  • Manufacturing Date YesGUDIDNoGUDID

Other properties (14)

  • 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