FDA Device recall Z-1265-2016

Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/f…

FDA Device
Class II
terminated
Published 2016-04-06

On 2016-04-06 the FDA classified a Class II recall of Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/f… by Biomet, citing 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 th….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1265-2016
Classification	Class II
Status	terminated
Initiated	2016-02-05
Published	2016-04-06
Last updated	2026-09-13 11:54 UTC
Company	Biomet
Distribution	UT

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.

Identifiers

code_info	Part number; Description; Lot number 195929 Vanguard XP Porous Femoral Rt 52.5 055330 195929 Vanguard XP Porous Fem… Part number; Description; Lot number 195929 Vanguard XP Porous Femoral Rt 52.5 055330 195929 Vanguard XP Porous Femoral Rt 52.5 105710 195929 Vanguard XP Porous Femoral Rt 52.5 105820 195929 Vanguard XP Porous Femoral Rt 52.5 273570 195929 Vanguard XP Porous Femoral Rt 52.5 727260 195929 Vanguard XP Porous Femoral Rt 52.5 727280 195930 Vanguard XP Porous Femoral Rt 55 054980 195930 Vanguard XP Porous Femoral Rt 55 727270 195930 Vanguard XP Porous Femoral Rt 55 727290 195930 Vanguard XP Porous Femoral Rt 55 727310 195930 Vanguard XP Porous Femoral Rt 55 886090 195930 Vanguard XP Porous Femoral Rt 55 961570 195930 Vanguard XP Porous Femoral Rt 55 961580 195931 Vanguard XP Porous Femoral Rt 57.5 054700 195931 Vanguard XP Porous Femoral Rt 57.5 054760 195931 Vanguard XP Porous Femoral Rt 57.5 054990 195931 Vanguard XP Porous Femoral Rt 57.5 055340 195931 Vanguard XP Porous Femoral Rt 57.5 105720 195931 Vanguard XP Porous Femoral Rt 57.5 105730 195931 Vanguard XP Porou

code_info

Part number; Description; Lot number 195929 Vanguard XP Porous Femoral Rt 52.5 055330 195929 Vanguard XP Porous Fem…

Part number; Description; Lot number 195929 Vanguard XP Porous Femoral Rt 52.5 055330 195929 Vanguard XP Porous Femoral Rt 52.5 105710 195929 Vanguard XP Porous Femoral Rt 52.5 105820 195929 Vanguard XP Porous Femoral Rt 52.5 273570 195929 Vanguard XP Porous Femoral Rt 52.5 727260 195929 Vanguard XP Porous Femoral Rt 52.5 727280 195930 Vanguard XP Porous Femoral Rt 55 054980 195930 Vanguard XP Porous Femoral Rt 55 727270 195930 Vanguard XP Porous Femoral Rt 55 727290 195930 Vanguard XP Porous Femoral Rt 55 727310 195930 Vanguard XP Porous Femoral Rt 55 886090 195930 Vanguard XP Porous Femoral Rt 55 961570 195930 Vanguard XP Porous Femoral Rt 55 961580 195931 Vanguard XP Porous Femoral Rt 57.5 054700 195931 Vanguard XP Porous Femoral Rt 57.5 054760 195931 Vanguard XP Porous Femoral Rt 57.5 054990 195931 Vanguard XP Porous Femoral Rt 57.5 055340 195931 Vanguard XP Porous Femoral Rt 57.5 105720 195931 Vanguard XP Porous Femoral Rt 57.5 105730 195931 Vanguard XP Porou

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1265-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.