Endo-Model SL Knee Prosthesis System 16-2840/07Recalls & reported problems

WALDEMAR LINK GmbH & Co. KG · Connection Components,Rotational version, neutral · Class 2 · Implant

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

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575359257), received between Aug 29, 2023 and Feb 13, 2026 — classified as 1 injury, 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

15 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.

Recalls naming this device

Jan 12, 2026Class IIOpen, Classified
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Z-1514-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

Activation Failure1
Adverse Event Without Identified Device or Use Problem1
Malposition of Device1

Patient problems

Medical device site infection1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem
NOTIFIED BY (B)(6) OF A REVISION TO A SPECIAL ACCESS ORDER WITH DR. (B)(6) BECAUSE OF AN INFECTED DISTAL FEMUR REQUIRING A WASHOUT AND EXCHANGE OF COMPONENTS. THE SURGEON STATED THAT IN HIS OPINION THE IMPLANT DID NOT CAUSE THE INFECTION. THE SURGEON BELIEVES THAT THE INFECTION IS DUE TO THE PATIENT BEING IMMUNOCOMPROMISED DUE TO CHEMOTHERAPY.
Patient problems: Medical device site infection
MAUDE report 24336335 ↗
MalfunctionAug 29, 2023Malposition of Device; Activation Failure; Malposition of Device; Activation Failure
CONNECTION COMPONENT AXIS DID NOT PROPERLY DEPLOY DURING SURGERY. BY MOVING THE LEG SEVERAL TIMES (EXTENSION, FLEXION, ROTATION), THE CONNECTOR REACHED THE DESIRED POSITION IN THE INTRACONDYLAR REGION, BUT THE AXIS DID NOT DEPLOY. THE CONNECTOR HAS BEEN EXCHANGED. [TRANSLATED DESCRIPTION FROM CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17641709 ↗

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-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-1516-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
Z-1521-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Z-1520-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Z-1517-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
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-1515-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
Z-1522-2026 · Jan 12, 2026 · Open, Classified
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
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-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
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

Device details

UDI-DI	`04026575359257`
Brand	Endo-Model SL Knee Prosthesis System
Model	16-2840/07
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	Jul 6, 2018

Device type (GMDN): Rotating hinged total knee prosthesis

A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the joint [total knee arthroplasty (TKA)] because of major loss of stabilizing structures or bone around the knee, often from tumour resection, or to replace a dysfunctional knee prosthesis (revision); it is designed with a mechanism for joint rotation and its major components are connected for stability typically about a transverse axis posterior of the rotational axis. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implated with or without 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 · each recall links to the FDA recall notice
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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