United Orthopedic Corporation recalls USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x1…

Recall date

January 3, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1217-2024

FDA classification

Class II

Brand / firm

United Orthopedic Corporation

Sold / distributed

US: CA,KY, MI, IN, TN, CO, FL, TX, NV, OUS: Switzerland, United Kingdom, Malaysia, Philippines, Taiwan

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 - 11X150, PE25151213 - 13X150mm, PE25151215 - 15X150mm, PE25151217 - 17X150mm, PE25151415 - 15x200mm