Recall Z-1265-2016— Biomet, Inc.

Name: FDA recall Z-1265-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-05

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2016-02-05, terminated 2017-03-28. It names one FDA 510(k) clearance: K141407. Product: 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. Reason: 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..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-02-05
Terminated: 2017-03-28
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K141407 — VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIALBiomet, Inc.·cleared 2014-10-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.