Endo-Model Knee System - Instruments 445-904/00Recalls & reported problems

WALDEMAR LINK GmbH & Co. KG · Orthopaedic implant aiming/guiding block, reusable - General instrument · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575184378), received between Sep 11, 2025 and Sep 11, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Detachment of Device or Device Component1
Fracture1

Patient problems

Foreign Body In Patient1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionSep 11, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATELLA CLAMP ARM BROKE AND CAME APART DURING A PROCEDURE AND THE CLIP THAT HOLDS THE ROUND PLASTIC SECTION ON THE ARM WAS LEFT IN THE WOUND. [CUSTOMER]
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 23024855 ↗

Device details

UDI-DI	`04026575184378`
Brand	Endo-Model Knee System - Instruments
Model	445-904/00
Company	WALDEMAR LINK GmbH & Co. KG
Product code	HTX · RONGEUR
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 13, 2023

Device type (GMDN): Orthopaedic prosthesis implantation positioning instrument, reusable

A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Other RONGEUR devices

SPOTLIGHT 292904201
Depuy Spine, LLC · RONGEUR
6 reports
Symmetry RapidClean® 58-3200J-BD
Aspen Surgical Products, Inc. · Rongeur
5 reports
SPOTLIGHT 292904202
Medos International Sàrl · RONGEUR
5 reports
NA 03.605.001
Synthes GmbH · RONGEUR
4 reports
SPOTLIGHT 292902240
Depuy Spine, LLC · RONGEUR
3 reports
Symmetry Rapidclean® 58-3200-BD
Aspen Surgical Products, Inc. · Rongeur
3 reports
Medicon 57.28.33
Medicon eG. Chirurgiemechaniker-Genossenschaft · RONGEUR
3 reports
AESCULAP FF805R
Aesculap AG · RONGEUR
3 reports

All RONGEUR devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.