United Orthopedic Corp. Recalls
9 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (9)
- Class II
May 20, 2026
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 Software Version: N/
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
- Class II
May 20, 2026
Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337,
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
- Class II
May 20, 2026
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A P
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
- Class II
May 20, 2026
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Sur
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
- Class II
March 19, 2026
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
- Class II
March 19, 2026
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
- Class II
January 3, 2024
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,
Their is a potential that the implant curved stem may be oriented incorrectly.
- Class II
January 3, 2024
USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153
Their is a potential that the implant curved stem may be oriented incorrectly.
- Class II
January 3, 2024
USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE2
Their is a potential that the implant curved stem may be oriented incorrectly.
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