"UNITED" USTAR II Knee System 2315-3243Recalls & reported problems

United Orthopedic Corp. · XPE Tibial insert, M, 17mm · Class 2 · Implant

All models of "UNITED" USTAR II Knee System (22)

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 04711605580397), received between Apr 29, 2026 and Apr 29, 2026 — classified as 1 injury.

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

5 other recalls cover devices cleared under the same FDA submission (K190100); 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

Break1
Deformation Due to Compressive Stress1
Fracture1

Patient problems

Hyperextension1

Recent adverse event reports

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

InjuryApr 29, 2026Break; Fracture; Deformation Due to Compressive Stress
A PATIENT UNDERWENT TKA SURGERY ON (B)(6) 2022. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO THE TIBIAL INSERT RUPTURE ON THE YOKE PART WAS OBSERVED BY X-RAYS.
Patient problems: Hyperextension
MAUDE report 25038513 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190100. One submission often covers many models, so check the product and lot details in each record.

Z-2884-2026 · May 20, 2026 · Open, Classified
Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Sof
Z-1215-2024 · Jan 3, 2024 · Open, Classified
USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE1
Z-1216-2024 · Jan 3, 2024 · Open, Classified
USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111-
Z-1217-2024 · Jan 3, 2024 · Open, Classified
USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE2515111
Z-0110-2022 · Aug 27, 2021 · Terminated
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025

Device details

UDI-DI	`04711605580397`
Brand	"UNITED" USTAR II Knee System
Model	2315-3243
Company	United Orthopedic Corp.
Product code	KRO · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Class	Class 2
FDA submission	K190100
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	Mar 2, 2020

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, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer devices

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"UNITED" USTAR II Hip System 1115-1413
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"UNITED" USTAR II Hip System 1115-1213
United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
3 recalls0 reports
"UNITED" USTAR II Hip System 1115-1417
United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
3 recalls0 reports
"UNITED" USTAR II Hip System 1115-1217
United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
3 recalls0 reports
Endo-Model Modular Knee Prosthesis System 15-3816/12
WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
2 recalls6 reports
Endo-Model Modular Knee Prosthesis System 15-3816/11
WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
2 recalls6 reports

All Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 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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