Endo-Model SL Knee Prosthesis System 16-2821/22Recalls & reported problems

WALDEMAR LINK GmbH & Co. KG · Femoral Component,intracondylar, with patellar flange · 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: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575392247), received between Apr 3, 2024 and Oct 2, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Expiration Date Error” (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

Expiration Date Error1
Nonstandard Device1

Patient problems

No Clinical Signs, Symptoms or Conditions2
Insufficient Information1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 2, 2025Nonstandard Device; Nonstandard Device
DIFFICULTIES WITH COUPLING, NOTICED MANUFACTURING DEFECT. [CUSTOMER].
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23197623 ↗
MalfunctionApr 3, 2024Expiration Date Error; Expiration Date Error
THE PROSTHESIS WAS IMPLANTED ON (B)(6) 2024 WHILE THE PACKAGING STATED THE EXPIRY DATE AS 31/01/2024. [CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19031240 ↗

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-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-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-1522-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
Z-1516-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
Z-1517-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
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-1518-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Z-1513-2026 · Jan 12, 2026 · Open, Classified
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Z-1511-2026 · Jan 12, 2026 · Open, Classified
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
Z-1521-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
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.

Device details

UDI-DI	`04026575392247`
Brand	Endo-Model SL Knee Prosthesis System
Model	16-2821/22
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	Dec 11, 2019

Device type (GMDN): Uncoated knee femur prosthesis, metallic

An implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation is intended to be performed with bone cement.

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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