Unicondylar Sled Prosthesis 15-2028/02Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-1512-2023 · Root cause: Labeling design · Recall details · FDA record ↗

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-1515-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05
• 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-1520-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10
• 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-1514-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04
• 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-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-1507-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40
• Z-1531-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07
• 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-1526-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16
• 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-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-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-1524-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14

…and 16 more.