LinkSymphoKnee 880-213/12Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04026575252961), received between Jun 1, 2023 and Jan 19, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2024Difficult or Delayed Positioning; Positioning Failure; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Positioning; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  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: Failure of Implant; No Clinical Signs, Symptoms or Conditions; Rupture

  MAUDE report 18542324 ↗
• MalfunctionJun 1, 2023Positioning Failure; Positioning Failure

  AS CONFIRMED TO LB COMPLAINTS ON (B)(6) 2022 PER K. N., THIS "POLY SEEMED TO NOT ENGAGE". IT WAS CONSIDERED WASTED. THE SURGERY TIME WAS NOT EXTENDED. THIS COMPLAINT SAMPLE WAS RETURNED DIRECTLY TO MANUFACTURER, WHO NOTIFIED LB ON (B)(6) 2022 UPON NOTICE OF ADDITIONAL COMPLAINTS FROM THE SAME DOCTOR, AS NOTED IN PREVIOUSLY INITIATED COMPLAINT (B)(4).. [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17040251 ↗
• MalfunctionJun 1, 2023Positioning Failure; Positioning Failure

  POSITIONING FAILURE OF ARTICULATING SURFACE IN THE TIBIAL COMPONENT. A DIFFERENT ARTICULATING SURFACE WAS USED INSTEAD WITHOUT ANY ISSUE. [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17040148 ↗

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-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-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-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-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-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.
• 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.