FDA-Device2016-04-06Class II
Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Biomet, Inc.
Hazard
The anterior/posterior (AP) dimension may be oversized by 0.016 . If the femoral component does not fit as tightly as intended, bony ingrowth may not occur causing loosening of the femoral component. A revision surgery may be necessary.
Sold states
UT Netherlands
Affected count
890
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1265-2016Don't want to check this manually?
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