Unicondylar Sled Prosthesis 15-2030/13Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575436705), received between Nov 21, 2024 and Nov 21, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (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-1536-2023 · Root cause: Labeling design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2024Degraded; Naturally Worn; Degraded; Naturally Worn

  OUR CLIENT HAD A CEMENTED SLED PROSTHESIS INSERTED ON THE RIGHT WE ENCLOSE THE SURGICAL REPORT AND THE X-RAYS. WE ENCLOSE A COPY OF THE IMPLANT ID. POSTOPERATIVELY, OUR CLIENT EXPERIENCED PAIN IN HER RIGHT KNEE AFTER SOME TIME. HOWEVER, DUE TO THE PANDEMIC, AN ARTHROSCOPY OF THE RIGHT KNEE JOINT WAS NOT PERFORMED UNTIL FEBRUARY 27, 2023 TO CLARIFY THE CAUSE OF THE COMPLAINTS. THIS REVEALED THE INDICATION FOR A PROSTHESIS CHANGE DUE TO PROSTHESIS FAILURE. [CUSTOMER].

  Patient problems: Failure of Implant; Pain

  MAUDE report 20743413 ↗

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-1525-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15
• Z-1514-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04
• Z-1526-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16
• Z-1538-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15
• Z-1517-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07
• 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-1512-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02
• Z-1522-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12
• Z-1535-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12
• 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-1508-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46
• Z-1510-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60
• Z-1529-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04
• Z-1520-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10

…and 16 more.