Endo-Model SL Knee Prosthesis System 16-2849/25Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575383375), received between Jun 8, 2024 and Jun 18, 2024 — 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.

• InjuryJun 18, 2024Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem

  RECENT WE DID A TWO SITE MEGA-C OPERATION REVISION INDICATION WITH BIG BONE LOSS AT THE TIBIA. TIBIAL REPLACEMENT ON BOTH SITES. 2 WEEKS AGO, WE DID A RE-FIXATION OF THE TIBIAL SCREWS ON THE LEFT SITE. WE DID AN ANALYZE OF WHAT THE PURPOSE OF THIS COULD HAVE BEEN. WITH THE CONCLUSION AFTER THE RE-OPERATION THAT IT WAS BEAD LUCK. BECAUSE NO REASONABLE REASON WAS OCCURRED. BUT TODAY WE RECEIVED THE SAME PROBLEM AT THE OTHER SITE. OLD PATIENT, NOT TO HAVE, WELL MOTIVATED, MOVING WITH RESTRICTION OF BRACES.[CUSTOMER] UPDATE: SEE THE EVENT INFORMATION FROM MY COLLEAGUE ABOUT THE SURGERY; WE OPENED THE KNEE, JUST UNDER THE PATELLA UNTIL WE CAME ACROSS THE PLATE. THE SCREWS WERE INDEED LOOSE AND THE LARS LIGAMENT WAS TORN LOOSE. WE REMOVED THE SCREWS AND CHECKED THEM. SEE PICTURES. THE LATERAL SCREW HAD A DENT 1/3 FROM THE TIP. IT WAS PROBABLY IN THE COMPONENT UP TO THAT POINT. THE MEDIAL SCREW SHOWED NO DAMAGE. WE REMOVED SOME SOFT TISSUE TO SEE IF WE COULD MAKE THE PLATE LAND BETTER AND ADD MORE TURNS TO THE COMPONENT. TRIED TO TIGHTEN THE SCREW TWICE. THEN THIS WORKS. TIGHTENED ALTERNATELY DURING THE LAST STROKES, SO ALTERNATED BETWEEN MEDIAL AND LATERAL. WITH THE LAST TURN OF THE LATE

  Patient problems: Insufficient Information

  MAUDE report 19558634 ↗
• InjuryJun 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  LAST MONTH WE DID A CASE WITH A LADY WHO RECEIVED ON BOTH SIDES A PROXIMAL TIBIA REPLACEMENT. THE SURGERIES WENT WELL BUT TODAY I RECEIVED THIS FOTO. THE SCREW WHICH FIXATES THE PATELLA TENDON TO THE PROSTHESIS CAME OUT. THE DOCTOR WANT TO REPLACE IT ON 17TH OF MAY. FOR THIS CASE WE NEED THE RIGHT SCREW AND IF POSSIBLE A BIT LONGER THAN THE CURRENT ONE.[CUSTOMER]

  Patient problems: Insufficient Information

  MAUDE report 19493078 ↗

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-1522-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/12;
• Z-1520-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/15;
• Z-1519-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/11;
• 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-1511-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
• Z-1516-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-2836/11;
• 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-1518-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/09;
• Z-1515-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-2835/12;
• Z-1517-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8030/12;
• Z-1513-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
• 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.