The Recall Desk

FDA (Devices) recall action 93858

United Orthopedic Corporation recalled 3 products on 2024-03-06

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2024-03-06
Critical
0
Units
1,077

Why these products were recalled

Their is a potential that the implant curved stem may be oriented incorrectly.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2024-03-06

    USTAR II Knee System implants recalled for potential stem misalignment

    The FDA is recalling USTAR II Knee System implants due to potential incorrect orientation of the curved stem. The defect may affect proper implant positioning in knee replacement surgery.

    Product
    USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153115 - 15x125mm, PE25153211 - 11x150mm, PE25153213 - 13x150mm, PE25153217 - 17x1
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2024-03-06

    Hip Implant System Recalled for Potential Incorrect Stem Orientation

    United Orthopedic Corporation is recalling the USTAR II Hip System Press-Fit Curved Stem due to a potential risk that the implant curved stem may be oriented incorrectly. The FDA Class II recall affects 598 units.

    Product
    USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, PE11151411 - 11x200mm, PE11151413 - 13x200mm, PE11151415 - 15x200mm, PE11151417
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2024-03-06

    Orthopedic knee implant recall due to potential stem misalignment

    United Orthopedic Corporation recalls USTAR II knee implants due to potential incorrect orientation of the curved stem. Affected products were distributed across multiple US states and internationally.

    Product
    USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE25151117 - 17X125mm, PE25151119 - 19X125mm, PE25151209 - 9X150mm, PE25151211 - 11
    Category
    Distribution
    9 states