Z-0644-2019 Class II Terminated
FDA device recall Z-0644-2019 was initiated by Zimmer GmbH on Oct 31, 2018 and is designated Class II. Reason for recall: Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 . The recall status is terminated (terminated Apr 1, 2020). Affected quantity: 13 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 26, 2018
- Initiation Date
- Oct 31, 2018
- Termination Date
- Apr 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
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 .
Distribution Pattern
International distribution in the countries of Germany and Switzerland.
Code Information
Lot Number:2955599 UDI Number:(01) 00889024479456(17)230831(10)2955599
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0644-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026