Avenir¿ Muller Stem Standard recalled over labeling errors

Recall date

October 31, 2018

Source

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

Official notice title

Zimmer GmbH recalls Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller S…

Recall number

Z-0644-2019

FDA classification

Class II

Brand / firm

Zimmer GmbH

Sold / distributed

International distribution in the countries of Germany and Switzerland.

Why it was recalled

Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .

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

What was recalled

Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cementless fixation of total or hemi hip arthroplasty in the femur of patients with an adequate bone stock to support the component. A system consisting of a stem, a ball head and a cup is used for the treatment of degenerative diseases or trauma of the hip. All Avenir Muller Stems are intended to provide connection to articulation with specified ball heads through the 12/14 taper. The stems may be used for total hip and hemi-hip arthroplasty. During total hip arthroplasty, the stems may be combined with constrained or semi-constrained acetabular systems.