Unicondylar Sled Prosthesis 15-2220/46Recalls & 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.

21 other recalls cover devices cleared under the same FDA submission (K152431, K212742); 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-1540-2023 · Root cause: Labeling design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152431, K212742. One submission often covers many models, so check the product and lot details in each record.

• Z-2410-2024 · May 22, 2024 · Open, Classified
  Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-281
• Z-2411-2024 · May 22, 2024 · Open, Classified
  Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75m
• Z-1549-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10
• Z-1552-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13
• Z-1553-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14
• Z-1545-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04
• Z-1554-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15
• Z-1541-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52
• Z-1539-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
• Z-1547-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07
• Z-1546-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06
• Z-1542-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60
• Z-1550-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11
• Z-1551-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12
• Z-1543-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02

…and 6 more.