Recall Z-0644-2019— Zimmer GmbH

Name: FDA recall Z-0644-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-31

Class II · Terminated

Class II FDA medical device recall by Zimmer GmbH, initiated 2018-10-31, terminated 2020-04-01. It names one FDA 510(k) clearance: K123392. Product: 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.. Reason: Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 ..

Recalling firm: Zimmer GmbH
Classification: Class II
Status: Terminated
Initiated: 2018-10-31
Terminated: 2020-04-01
Firm location: Winterthur, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K123392 — AVENIR MULLER STEMZimmer GmbH·cleared 2013-03-04

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

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.

Reason for recall

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

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