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LinkSymphoKnee 880-323/23

by WALDEMAR LINK GmbH & Co. KG

Ref 880-323/23Model Femoral augments, cemented, Ti6Al4V, CoCrMo, L-shaped

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

3 Feb 2030

CE MDR certificate

FDA recalls

11 ongoing

This device is named in the recall

Documents

1 certificate

Certifier DNV MEDCERT GmbH

510(k) K202924

FDA submission, from GUDID

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-KNP-203030-VF Basic UDI-DI 04026575258109UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575258109 UDI-DI Date7 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK202924 Date13 May 2021DecidedStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13697GB450250204 Active

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 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).

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
LinkSymphoKnee
Generic name
Knee arthroplasty wedge
Model / Ref / Catalog
880-323/23, Femoral augments, cemented, Ti6Al4V, CoCrMo, L-shaped
Primary DI / UDI-DI
04026575258109
Basic UDI-DI
4026575-1-KNP-203030-VF
510(k) Number
FDA product code
HRY, KRO, HSX, JWH
EMDN code
P09098001 Knee prostheses augments
GMDN term
Knee arthroplasty wedge
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3530, 888.3510, 888.3520, 888.3560
EU registration type
Standard device
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 arthroplasty wedge

Cleared under the same submission (K202924)

Show all (12)

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (18)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No