Z-0644-2019Class II

Avenir Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 -

Name: Z-0644-2019 Avenir Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 -
Creator: Zimmer GmbH
Published: 2018-10-31
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-10-31 / Terminated / root cause: manufacturing process

FDA source

Zimmer GmbH began a recall of 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... on 2018-10-31. FDA classified it as Class II and gives the reason as "Mislabeled Labeled Avenir Mller Stem size 1, the stem inside the packaging is an Avenir Mller Stem size 2". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0644-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-31
Posted: 2018-12-20
Terminated: 2020-04-01
Recalling firm: Zimmer GmbH
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.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Mislabeled Labeled Avenir Mller Stem size 1, the stem inside the packaging is an Avenir Mller Stem size 2 .
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer Biomet issued Notices to the OUS consignees on October 31, 2018. Letter identifies action to be taken: Review this notice and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement
Quantity in commerce: 13 units
Distribution: International distribution in the countries of Germany and Switzerland.
Product codes and lots: Lot Number:2955599 UDI Number:(01) 00889024479456(17)230831(10)2955599

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0644-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0644-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-20

Product code LZO

K123392Class IIAvenir Muller StemZimmer GmbH / cleared 2013-03-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)