Gemini SL 318-328/05Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575412204), received between Dec 16, 2025 and Dec 16, 2025 — classified as 1 injury.

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

22 other recalls cover devices cleared under the same FDA submission (K182872, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

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.

• InjuryDec 16, 2025Fracture; Fracture

  SCREW BREAKAGE BETWEEN INLAY AND TIBIAL COMPONENT [CUSTOMER].

  Patient problems: Insufficient Information

  MAUDE report 23813656 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182872, K212742. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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
• 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-1540-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46
• 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-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-1544-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03
• 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-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-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-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-1548-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08
• Z-1541-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52

…and 7 more.