"UNITED" USTAR II Knee System 2915-1025Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04719872148197), received between Aug 13, 2021 and Jun 29, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name this device's identifier.

4 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. Aug 27, 2021Class IITerminated

   Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.

   Z-0110-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2023Break; Break

  UPON X-RAY EVALUATION DR. (B)(6) DETERMINED THE 25-MM SEGMENT ON THE FEMORAL SIDE HAD BROKEN. A REVISION SURGERY WAS SCHEDULED, AND THE 25-MM SEGMENT WAS SUCCESSFULLY EXTRACTED AND REPLACED WITH A UNITED 30-MM SEGMENT ON (B)(6) 23.

  Patient problems: Hip Fracture

  MAUDE report 17222914 ↗
• MalfunctionFeb 10, 2022Break; Break

  PER THE PATIENT THEY FELT THEY BROKE SOMETHING WHILE WALKING ON A LEVEL SURFACE. UPON X-RAY EVALUATION IT WAS DETERMINED THE 25MM SEGMENT HAD FRACTURED. DR. (B)(6) PERFORMED A LEFT REVISION SURGERY AND EX-PLANTED THE 25MM SEGMENT.

  Patient problems: Hip Fracture

  MAUDE report 13510462 ↗
• MalfunctionAug 13, 2021Break; Break

  IT WAS REPORTED TO UNITED ORTHOPEDIC THAT A PATIENT WHO HAD UNDERGONE A PRIOR HIP PRIMARY SURGERY, HAD TO TO BE REVISED AFTER PRESENTING TO THE HOSPITAL AFTER A MISSED STEP FALL ON PATIENTS RIGHT SIDE. RADIOGRAPHS INDICATED THE SEGMENT ON THE LEFT.

  Patient problems: Hip Fracture

  MAUDE report 12317205 ↗

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