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LinkSymphoKnee 881-119/80

by WALDEMAR LINK GmbH & Co. KG

LinkSymphoKnee 881-119/80 is a Class II device made by WALDEMAR LINK GmbH & Co. KG, cleared under FDA 510(k) K202924 on 13 May 2021 and listed in FDA GUDID since 7 Oct 2021 (UDI-DI 04026575305155), active as of 23 Oct 2026. 11 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

11 ongoing

This device is named in the recall

Documents

510(k) K202924

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04026575305155 UDI-DI Date7 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK202924 Date13 May 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K202924 decided 13 May 2021 Active
  • FDA GUDID UDI-DI 04026575305155 listed 7 Oct 2021 Listed

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).

Timeline

13 dated events

  1. Recall initiated FDA recalls Z-2067-2023
  2. Recall initiated FDA recalls Z-1674-2023
  3. Recall initiated FDA recalls Z-1372-2025
  4. Recall initiated FDA recalls Z-1374-2025
  5. Recall initiated FDA recalls Z-1373-2025
  6. Recall initiated FDA recalls Z-1702-2025
  7. Recall initiated FDA recalls Z-1700-2025
  8. Recall initiated FDA recalls Z-1699-2025
  9. Recall initiated FDA recalls Z-1701-2025
  10. Recall initiated FDA recalls Z-2541-2025

3 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
LinkSymphoKnee
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
881-119/80
Primary DI / UDI-DI
04026575305155
510(k) Number
FDA product code
KRO, HRY, HSX, JWH
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class II
Regulation number
888.3510, 888.3530, 888.3520, 888.3560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K202924)

and 8 more cleared under K202924

Similar devices in this category

Other devices filed under Orthopaedic prosthesis implantation positioning instrument, reusable.

Other devices from WALDEMAR LINK GmbH & Co. KG

See all devices from WALDEMAR LINK GmbH & Co. KG →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)