Biomet, Inc. recalls Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthe…

Recall date

February 5, 2016

Source

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

Recall number

Z-1265-2016

FDA classification

Class II

Brand / firm

Biomet, Inc.

Sold / distributed

UT Netherlands

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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