Medical Device Recall: 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,
United Orthopedic Corporation · January 3, 2024
Reason for Recall
Their is a potential that the implant curved stem may be oriented incorrectly.
Product Description
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,
Distribution
US: CA,KY, MI, IN, TN, CO, FL, TX, NV, OUS: Switzerland, United Kingdom, Malaysia, Philippines, Taiwan
States Affected
CA, CO, FL, IN, KY, MI, NV, TN, TX
Quantity Affected
598 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1215-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.