Endo-Model SL Knee Prosthesis System 15-8523/50Recalls & reported problems

WALDEMAR LINK GmbH & Co. KG · Modular Stem, with male taper for 6mm noses, cementless · Class 2 · Implant

All models of Endo-Model SL Knee Prosthesis System (25)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575384082), received between Jan 15, 2026 and Jan 15, 2026 — classified as 1 injury.

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

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fracture1
Osseointegration Problem1

Patient problems

Insufficient Information1

Recent adverse event reports

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

InjuryJan 15, 2026Fracture; Osseointegration Problem
COMPLETE FRACTURE OF THE STEM BODY.
Patient problems: Insufficient Information
MAUDE report 24078073 ↗

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-1514-2026 · Jan 12, 2026 · Open, Classified
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Z-1515-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
Z-1523-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Z-1517-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Z-1512-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
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-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-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-1511-2026 · Jan 12, 2026 · Open, Classified
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
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-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.

Device details

UDI-DI	`04026575384082`
Brand	Endo-Model SL Knee Prosthesis System
Model	15-8523/50
Company	WALDEMAR LINK GmbH & Co. KG
Product code	LWJ · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Class	Class 2
FDA submission	K151008
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 20, 2020

Device type (GMDN): Knee femur stem prosthesis

A sterile device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone. It is typically a shaft-like device made of metal [e.g., cobalt-chrome (Co-Cr)] and is often used in prosthesis revision to compensate for bone loss.

Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented devices

LFIT 6260-9-136
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented
166 reports
Trident 623-00-36E
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented
112 reports
Accolade 6021-0435
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented
88 reports
EXETER 0580-1-044
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented
1 recall22 reports
Endo-Model SL Knee Prosthesis System 16-2840/02
WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
1 recall17 reports
Endo-Model SL Knee Prosthesis System 16-2840/05
WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
1 recall12 reports
Trident 623-10-36E
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented
57 reports
LFIT 6260-9-336
Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented
56 reports

All Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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