United Orthopedic Corporation recalls USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 1…

Recall date

January 3, 2024

Source

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

Recall number

Z-1215-2024

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 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 - 17x200mm,