FDA-Device2024-03-06Class II
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,
United Orthopedic Corporation
Hazard
Their is a potential that the implant curved stem may be oriented incorrectly.
Sold states
US: CA,KY, MI, IN, TN, CO, FL, TX, NV, OUS: Switzerland, United Kingdom, Malaysia, Philippines, Taiwan
Affected count
598 units
Manufactured in
No. 57 Park Avenue 2, Science Park, Hsinchu, Taiwan
Products
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,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1215-2024Don't want to check this manually?
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