Endo-Model SL Knee Prosthesis System 16-2857/21Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575383344), received between Apr 29, 2026 and May 6, 2026 — classified as 2 injuries.

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.

• InjuryMay 6, 2026Detachment of Device or Device Component

  A DFR COMPONENT WILL BE REVISED ON (B)(6) 2026 AS IT APPEARS TO HAVE FAILED BUSHINGS/INTERNAL COMPONENTS. THE PART WAS IMPLANTED ON (B)(6) 2019 [CUSTOMER].

  Patient problems: Insufficient Information

  MAUDE report 25092312 ↗
• InjuryApr 29, 2026Detachment of Device or Device Component

  UNKNOWN EVENT DATE: NOTIFIED BY (B)(6) THAT A DFR COMPONENT WILL BE REVISED ON (B)(6) 2026 BY DR. (B)(6) AS IT APPEARS TO HAVE FAILED BUSHINGS/INTERNAL COMPONENTS. THE PART WAS IMPLANTED ON (B)(6) 2019 BY DR.(B)(6).

  Patient problems: Joint Laxity

  MAUDE report 25035972 ↗

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-1511-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
• Z-1519-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/11;
• Z-1512-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/15;
• Z-1513-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
• Z-1523-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/16;
• Z-1522-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/12;
• Z-1521-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/11;
• Z-1518-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/09;
• Z-1517-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8030/12;
• Z-1520-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/15;
• Z-1515-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-2835/12;
• Z-1514-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
• 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.