Zimmer GmbH: Medical Device Recall in 2018 - (Recall #: Z-0644-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 31, 2018

Date Posted: December 26, 2018

Recall Number: Z-0644-2019

Event ID: 81608

Reason for Recall:

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

Status: Terminated

Product Quantity: 13 units

Code Information:

Lot Number:2955599 UDI Number:(01) 00889024479456(17)230831(10)2955599

Distribution Pattern:

International distribution in the countries of Germany and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated