Medical Device Recall: 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
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 Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153115 - 15x125mm, PE25153211 - 11x150mm, PE25153213 - 13x150mm, PE25153217 - 17x150mm, PE25153117 - 17x125mm, PE25153015 - 15x100mm, PE25153215 - 15x150mm
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
479 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1216-2024
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.