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Zimmer GmbH recalls Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller St
Recalled December 26, 2018 · FDA recall Z-0644-2019 · Zimmer
Hazard
Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 . · FDA Class II
Units
13 units
Sold at
International distribution in the countries of Germany and Switzerland.
Description
Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .
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.
Manufacturer(s)
Zimmer GmbH
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →