Endo-Model SL Knee Prosthesis System 15-8523/44Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575384242), received between Jul 25, 2023 and Aug 10, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

16 other recalls cover devices cleared under the same FDA submission (K151008); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY REPRESENTATIVE, ON 2023-07-12, AFTER A SURGERY PERFORMED ON (B)(6) 2023,THE STEM DISASSOCIATED FROM THE FEMUR, AFTER BEING CEMENTED WHEN PATIENT WAS MOVED FROM OR TO RECOVERY, APPROXIMATELY 45 MINUTES AFTER SURGERY. THE PRODUCT SEEMED WELL FIXED WITH CEMENT PRIOR TO CLOSING. [CUSTOMER].

  Patient problems: Failure of Implant

  MAUDE report 17496505 ↗
• InjuryJul 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY REPRESENTATIVE T.A., ON 2023-07-12, AFTER A SURGERY PERFORMED ON (B)(6) 2023 WITH DR. (B)(6), THE STEM DISASSOCIATED FROM THE FEMUR, AFTER BEING CEMENTED WHEN PATIENT WAS MOVED FROM OR TO RECOVERY, APPROXIMATELY 45 MINUTES AFTER SURGERY.

  Patient problems: Joint Laxity

  MAUDE report 17390839 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151008. One submission often covers many models, so check the product and lot details in each record.

• Z-1518-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/09;
• Z-1514-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
• Z-1512-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/15;
• Z-1522-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/12;
• Z-1513-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
• Z-1517-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8030/12;
• Z-1523-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/16;
• Z-1521-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/11;
• Z-1511-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
• Z-1515-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-2835/12;
• Z-1519-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/11;
• Z-1520-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/15;
• Z-1516-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-2836/11;
• Z-0890-2026 · Nov 10, 2025 · Open, Classified
  Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
• 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

…and 1 more.