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LinkSymphoKnee 880-413/23

by WALDEMAR LINK GmbH & Co. KG EUDAMEDGUDID

Active European Union Open recall

Ref 880-413/23Model Tibial component, cemented, UHMWPE, All Poly, PS, monoblock

Regulatory status

as of 28 Oct 2026

Recall ongoing. 11 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-KNP-203014-VH Basic UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575258741 UDI-DIDate7 Oct 2021ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13697GB450250204 Active

    Technical documentation EU MDR

    Notified body
    0482
    Issued
    4 Feb 2025
    Expires
    3 Feb 2030

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).

Specification

EUDAMED · GUDID

Trade Name
LinkSymphoKnee
Generic Name
Uncoated knee tibia prosthesis, polyethylene
Model / Ref / Catalog
880-413/23, Tibial component, cemented, UHMWPE, All Poly, PS, monoblock
Primary DI / UDI-DI
04026575258741
Basic UDI-DI
4026575-1-KNP-203014-VH
510(k) Number
FDA Product Code
HRY, KRO, JWH, HSX
EMDN Code
P090903020301 Bicompartmental primary implant tibial components, monoblock made of polyethylene
GMDN Term
Uncoated knee tibia prosthesis, polyethylene
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3530, 888.3510, 888.3560, 888.3520
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 knee tibia prosthesis, polyethylene

Cleared under the same submission (K202924)

Show all (12)

Other devices from WALDEMAR LINK GmbH & Co. KG

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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