Endo-Model SL Knee Prosthesis System 16-2821/21Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575392230), received between Apr 11, 2025 and Apr 11, 2025 — classified as 1 injury.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IN (B)(6) 2024, THE PATIENT DEVELOPED ABNORMAL SOUND IN THE RIGHT KNEE JOINT WITHOUT OBVIOUS CAUSE, AND THEN HE WAS TREATED IN OUR HOSPITAL. IN (B)(6) 2024, THE IMAGING EXAMINATION SHOWED THE POSTOPERATIVE PERFORMANCE OF THE RIGHT KNEE JOINT. THERE WAS NO OBVIOUS PROSTHESIS FRACTURE, AND THE MEDIAL AND LATERAL GAPS OF THE RIGHT KNEE ARTIFICIAL JOINT WERE UNEQUAL. ON (B)(6) 2024, THE RIGHT KNEE ARTIFICIAL JOINT REVISION WAS PERFORMED, AND THE MEDIAL AND LATERAL FEMORAL CONDYLE GASKETS WERE FRACTURED AND DAMAGED. LINK SMALL FEMORAL CONDYLE AND SMALL CONNECTING SHAFT WERE REPLACED. THE PATIENT RECOVERED SMOOTHLY AFTER THE OPERATION AND WAS DISCHARGED ON (B)(6) 2024. [CUSTOMER].

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21823491 ↗

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-1521-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/11;
• Z-1516-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-2836/11;
• Z-1522-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/12;
• Z-1517-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8030/12;
• Z-1515-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-2835/12;
• Z-1513-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
• Z-1520-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/15;
• 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-1519-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/11;
• Z-1523-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/16;
• Z-1512-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/15;
• Z-1511-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
• 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-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

…and 1 more.