"UNITED" USTAR II Knee System 2515-1217Recalls & reported problems

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

1. 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 ↗

2. 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, 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-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