LinkSymphoKnee 880-307/11Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575257379), received between Aug 2, 2023 and Aug 2, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

9 other recalls cover devices cleared under the same FDA submission (K202924); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Apr 3, 2025Open, Classified

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

   Z-1699-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Dec 23, 2022Open, Classified

   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).

   Z-2066-2023 · Root cause: Component change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2023Component Misassembled; Component Misassembled

  SCREWS THAT ATTACH AUGMENT TO FEM COMPONENT WERE PUT INTO AUGMENTS BACKWARDS. SCREWS SHOULD BE FED FROM PROX TO DISTAL. THERE WERE FED THROUGH THE AUGMENT FROM DISTAL TO PROXIMAL THUS CAUSING THE SURGEON TO HAVE TO REMOVE THEM AND REINSERT THEM. THE PATIENT IN NO WAY WAS AFFECTED AND THE SURGERY PROCEEDED AS PLANNED. DR.S. DOES NOT WANT OR NEED ANY FOLLOW UP. HAS SPECIFICALLY ASKED TO JUST INFORM LINK SO THEY CAN CORRECT THE PROBLEM MOVING FORWARD. CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446078 ↗
• MalfunctionAug 2, 2023Component Misassembled; Component Misassembled

  DR.(B)(6) WAS IN A SURGERY ON (B)(6) 2023 AND HAD AUGMENTS THAT WERE PACKAGED WITH THE SCREWS ASSEMBLED FROM THE INCORRECT SIDE. SCREWS WERE REMOVED AND PUT INTO OTHER SIDE AND AUGMENTS WERE IMPLANTED. NO CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442438 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K202924. One submission often covers many models, so check the product and lot details in each record.

• Z-2541-2025 · Jul 31, 2025 · Open, Classified
  LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
• Z-1702-2025 · Apr 3, 2025 · Open, Classified
  Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - ce
• Z-1701-2025 · Apr 3, 2025 · Open, Classified
  L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2
• Z-1700-2025 · Apr 3, 2025 · Open, Classified
  Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2
• Z-1373-2025 · Feb 14, 2025 · Open, Classified
  Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
• Z-1374-2025 · Feb 14, 2025 · Open, Classified
  Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
• Z-1372-2025 · Feb 14, 2025 · Open, Classified
  Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
• Z-1674-2023 · Apr 25, 2023 · Open, Classified
  LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-32
• Z-2067-2023 · Dec 23, 2022 · Open, Classified
  LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients.