LinkSymphoKnee 880-215/10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04026575253159), received between Feb 24, 2023 and Apr 10, 2024 — classified as 2 injuries, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  FEMUR HAT SICH VOM SCHAFT GELÖST. PATIENT IST ANSCHEINEND SO SCHON SEIT LÄNGER ZEIT RUM GELAUFEN. SCHAFT WAR FEST IM. ZEMENTMANTEL. [CUSTOMER]. TRANSLATION: FEMUR HAS DETACHED FROM THE STEM.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19077844 ↗
• MalfunctionApr 8, 2024Positioning Failure; Positioning Failure

  THE INSERT DOES NOT FULLY ADHERE TO THE TIBIA AT THE FRONT AND THEREFORE DOES NOT LOCK. THE ITEM WAS DISCARDED BECAUSE OF THIS MALFUNCTION AND WE USED ANOTHER NEW INSERT (PS+), WHICH FITTED AT THE FIRST ATTEMPT WITHOUT ANY PROBLEM. [CUSTOMER]. UPDATE: THE ITEM IS NOT DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057527 ↗
• MalfunctionJul 27, 2023Positioning Failure; Positioning Failure

  THE INSERT DOES NOT ATTACH TO THE TIBIAL PROSTHESIS. THE ITEM WAS DISCARDED BECAUSE OF THIS MALFUNCTION AND WE USED ANOTHER NEW INSERT, WHICH FITTED AT THE FIRST ATTEMPT WITHOUT ANY PROBLEM [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17403281 ↗
• InjuryFeb 24, 2023Positioning Failure; Device Dislodged or Dislocated; Positioning Failure; Device Dislodged or Dislocated

  POLY DISASSOCIATED FROM TIBIAL PLAUTEAU.

  Patient problems: Failure of Implant

  MAUDE report 16435634 ↗

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-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-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-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-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.