Unicondylar Sled Prosthesis 15-2020/60Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575043910), received between Sep 1, 2022 and Aug 27, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Crack” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

31 other recalls cover devices cleared under the same FDA submission (K954186); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 21, 2023Open, Classified

   Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

   Z-1510-2023 · Root cause: Labeling design · 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.

• InjuryAug 27, 2024Crack; Crack

  THE FINDINGS FROM THE ARTHROSCOPY WERE: HYPERPLASTIC YELLOWISH SYNOVIAL MEMBRANE WITH RED AND BROWN SPECKLING, WITH BIOPSIES TAKEN FROM THESE SPOTS AND THE SYNOVIAL FLUID. PATELLAR CHONDROMALACIA GRADE II-III AFFECTING APPROXIMATELY 30% OF THE PATELLA. NORMAL TROCHLEA, LATERAL COMPARTMENT WITH A ZONE OF APPROXIMATELY 5 X 3 MM OF CHONDROMALACIA GRADE II-II IN THE LATERAL FEMORAL CONDYLE, AND INTACT CRUCIATE LIGAMENTS.[CUSTOMER].

  Patient problems: Failure of Implant; Pain

  MAUDE report 20074618 ↗
• InjurySep 1, 2022Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  FRACTURE.

  Patient problems: Failure of Implant

  MAUDE report 15333900 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954186. One submission often covers many models, so check the product and lot details in each record.

• Z-1527-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02
• Z-1533-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2030/10
• Z-1516-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06
• Z-1537-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14
• Z-1530-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06
• Z-1532-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08
• Z-1515-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05
• Z-1513-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03
• Z-1536-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13
• Z-1526-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16
• Z-1518-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Number: 15-2028/08
• Z-1509-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52
• Z-1523-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13
• Z-1520-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10
• Z-1511-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01

…and 16 more.