"UNITED" USTAR II Knee System 2515-3115Recalls & reported problems
United Orthopedic Corp. · Cemented curved stem, RHS, non coated, Ø15×125mm · Class 2 · Implant
All models of "UNITED" USTAR II Knee System (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier, 2 still open.
3 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.
Recalls naming this device
- Jan 3, 2024Class IIOpen, Classified
Their is a potential that the implant curved stem may be oriented incorrectly.
Z-1216-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Jan 3, 2024Class IIOpen, Classified
Their is a potential that the implant curved stem may be oriented incorrectly.
Z-1217-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
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, ClassifiedBrand 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, ClassifiedUSTAR 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 · TerminatedUnited Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Other Prosthesis, Hip, Hemi-, Femoral, Metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- V40 Head 6260-9-122Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall10 reports
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
- 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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