"UNITED" USTAR II Knee System 2315-3211Recalls & reported problems

United Orthopedic Corp. · XPE Tibial insert, S, 12mm · 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 04711605580304), received between Apr 29, 2026 and Apr 29, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Align” (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

Failure to Align1
Fracture1
Mechanics Altered1

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, 2026Fracture; Failure to Align; Mechanics Altered
THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2024 THAT A PATIENT HAD UNDERGONE KNEE ARTHROPLASTY TWO YEARS EARLIER. THE PATIENT LATER RETURNED FOR FOLLOW-UP DUE TO PAIN, AND X-RAY IMAGES SHOWED FRACTURES OF THE SCREW AND THE METAL PORTION OF THE INSERT. A REVISION SURGERY WAS SUBSEQUENTLY PERFORMED.
Patient problems: Hyperextension
MAUDE report 25038512 ↗

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-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-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-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-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	`04711605580304`
Brand	"UNITED" USTAR II Knee System
Model	2315-3211
Company	United Orthopedic Corp.
Product code	KWL · Prosthesis, Hip, Hemi-, Femoral, Metal
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	Jan 1, 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, Hip, Hemi-, Femoral, Metal devices

UHR UH1-48-28
Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal
2 recalls3 reports
"UNITED" USTAR II Knee System 2515-3111
United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal
2 recalls0 reports
"UNITED" USTAR II Knee System 2515-3213
United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal
2 recalls0 reports
STAGEONE 431207
Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal
2 recalls0 reports
"UNITED" USTAR II Knee System 2515-3115
United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal
2 recalls0 reports
ACTIS 101011050
Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal
73 reports
UHR UH1-46-26
Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal
1 recall11 reports
UHR UH1-45-26
Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal
1 recall11 reports

All Prosthesis, Hip, Hemi-, Femoral, Metal 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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