CLASS II Device recall · Reported 26 Dec 2018 · FDA Enforcement Report
Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 recalled
Zimmer is recalling Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14, distributed nationwide in the US. The recall was initiated on 31 Oct 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0644-2019
- FDA event ID
- 81608
- Recalling firm
- Zimmer, Winterthur
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Oct 2018
- FDA classified
- 20 Dec 2018
- Reported
- 26 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 31 Oct 2018 | Recall initiated by company | |
| 20 Dec 2018 | Classified by FDA | +50 days |
| 26 Dec 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .
Product as listed by the FDA
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.
Where it was distributed
International distribution in the countries of Germany and Switzerland.
Stores named: Walmart
Questions about this recall
Is Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 recalled?
Yes. Zimmer recalled Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 on 31 Oct 2018. The recall is Class II and its status is Terminated. Recall number Z-0644-2019.
Why was it recalled?
Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .
Which lots are affected?
Lot Number:2955599 UDI Number:(01) 00889024479456(17)230831(10)2955599
Where was it sold?
International distribution in the countries of Germany and Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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