LinkSymphoKnee 880-213/11Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575252954), received between Jan 19, 2024 and Jan 19, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 reports).

11 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 18, 2026.

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.

• MalfunctionJan 19, 2024Positioning Failure; Positioning Failure

  DURING THE SURGERY, AFTER IMPLANTING THE TIBIAL COMPONENT, THE SURGEON TRIED TO INSERT THE POLY COMPONENT WHICH STRUGGLED TO ENTER, AND ABOVE ALL, DID NOT FIX WITH THE CLASSIC SNAP. THINKING THAT THE PE WAS FAULTY, HE OPENED A SECOND IDENTICAL ONE, BUT THE PROBLEM REPEATED ITSELF. NOT KNOWING WHAT TO DO, NOBODY OF US WAS IN THE OPERATING ROOM, A THIRD COMPONENT OF A HIGHER THICKNESS AS OPENED BUT AGAIN HE HAD DIFFICULTY INSERTING THE COMPONENT AND DIDN'T HEAR THE USUAL CLACKING. AT THIS POINT, HOPING THAT THE INSERT WAS FIXED AND STABLE, BUT WITH SOME CONCERN, THE SURGERY WAS FINISHED. [CUSTOMER]

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18542329 ↗
• MalfunctionJan 19, 2024Positioning Failure; Positioning Failure

  DURING THE SURGERY, AFTER IMPLANTING THE TIBIAL COMPONENT, THE SURGEON TRIED TO INSERT THE POLY COMPONENT WHICH STRUGGLED TO ENTER, AND ABOVE ALL, DID NOT FIX WITH THE CLASSIC SNAP. THINKING THAT THE PE WAS FAULTY, THE SURGEON OPENED A SECOND IDENTICAL ONE, BUT THE PROBLEM REPEATED ITSELF. NOT KNOWING WHAT TO DO, NONE OF US WAS IN THE OR, A THIRD COMPONENT OF A HIGHER THICKNESS WAS OPENED BUT AGAIN, THE SURGEON HAD DIFFICULTY INSERTING THE COMPONENT AND DIDN'T HEAR THE USUAL CLACKING. AT THIS POINT, HOPING THAT THE INSERT WAS FIXED AND STABLE, BUT WITH SOME CONCERN, THE SURGERY WAS FINISHED. [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18542325 ↗

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-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-1699-2025 · Apr 3, 2025 · Open, Classified
  Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 -
• 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-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-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-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.
• Z-2066-2023 · Dec 23, 2022 · Open, Classified
  LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients.