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LINK Endo-Model EVO 15-2953/11

by WALDEMAR LINK GmbH & Co. KG

Ref 15-2953/11Model Modular stem, uncemented, Ti6Al4V, conical (EVO)

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

CE MDR

Valid until

28 Sep 2028

CE MDR certificate

FDA recalls

11 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-KNR-251054-YW Basic UDI-DI 04026575275038UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575275038 UDI-DI Date7 Oct 2021ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13804GB450250207 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    7 Feb 2025
    Expires
    28 Sep 2028
    Reason
    Add device or group

Recalls

11 recalls · 11 ongoing · FDA

    • Ongoing Z-2541-2025 FDA Class II initiated 31 Jul 2025

    Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.

  • 4 recalls, same reason

    • Ongoing Z-1702-2025 FDA Class II initiated 3 Apr 2025
    • Ongoing Z-1700-2025 FDA Class II initiated 3 Apr 2025
    • Ongoing Z-1699-2025 FDA Class II initiated 3 Apr 2025
    • Ongoing Z-1701-2025 FDA Class II initiated 3 Apr 2025

    The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

  • 3 recalls, same reason

    • Ongoing Z-1372-2025 FDA Class II initiated 14 Feb 2025
    • Ongoing Z-1374-2025 FDA Class II initiated 14 Feb 2025
    • Ongoing Z-1373-2025 FDA Class II initiated 14 Feb 2025

    A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.

    • Ongoing Z-1674-2023 FDA Class II initiated 25 Apr 2023

    Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).

  • 2 recalls, same reason

    • Ongoing Z-2066-2023 FDA Class II initiated 23 Dec 2022
    • Ongoing Z-2067-2023 FDA Class II initiated 23 Dec 2022

    Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).

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
LINK Endo-Model EVO
Generic Name
Knee femur stem prosthesis
Device Name
Endo-Model Knee System / LINK Endo-Model EVO Knee System
Model / Ref / Catalog
15-2953/11, Modular stem, uncemented, Ti6Al4V, conical (EVO)
Primary DI / UDI-DI
04026575275038
Basic UDI-DI
4026575-1-KNR-251054-YW
510(k) Number
FDA Product Code
HRY, HSX, KRO, JWH
EMDN Code
P0909800601, P0909800602
GMDN Term
Knee femur stem prosthesis
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3530, 888.3520, 888.3510, 888.3560
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: Knee femur stem prosthesis

Cleared under the same submission (K202924)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No