LinkSymphoKnee System

• • 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).

1. 23 Dec 2022 Recall initiated FDA recalls Z-2067-2023
2. 25 Apr 2023 Recall initiated FDA recalls Z-1674-2023
3. 14 Feb 2025 Recall initiated FDA recalls Z-1372-2025
4. 14 Feb 2025 Recall initiated FDA recalls Z-1374-2025
5. 14 Feb 2025 Recall initiated FDA recalls Z-1373-2025
6. 3 Apr 2025 Recall initiated FDA recalls Z-1702-2025
7. 3 Apr 2025 Recall initiated FDA recalls Z-1700-2025
8. 3 Apr 2025 Recall initiated FDA recalls Z-1699-2025
9. 3 Apr 2025 Recall initiated FDA recalls Z-1701-2025
10. 31 Jul 2025 Recall initiated FDA recalls Z-2541-2025

2 earlier events are in the sections above.

510(k) Number

K202924 ↗

FDA product code

JWH

Device class

Class II

Regulation

21 CFR Part 888.3560

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

• AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE by Depuy, Inc.
• APEX Revision Knee KP-39020 by OMNIlife science, Inc.
• Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System by Conformis, Inc.
• Persona® 42-5801-175-18 by Zimmer, Inc.
• DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION by Howmedica Corp.
• U2 Total Knee System 2303-4514 by UNITED ORTHOPEDIC CORP.
• VEGA KNEE SYSTEM by Aesculap Implant Systems, Inc.
• PHYSICA PS Right Femoral Comp. 6515.09.140 by Limacorporate
• GMK Total Knee System 02.12.KA54L by Medacta International SA
• TRUMATCH Personalized Solutions by DEPUY ORTHOPAEDICS, INC.

• MP Reconstruction System 134-518/12

  Class I

  GUDID on market

• General Instrument 15-8380/02B

  Class I

  GUDID on market

• MP Reconstruction System 134-518/13

  Class I

  GUDID on market

• MP Reconstruction System 134-518/14

  Class I

  GUDID on market

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