CLASS II Device recall · Reported 2 May 2018 · FDA Enforcement Report

Avenir Muller Stem recalled by Zimmer

Zimmer is recalling Avenir Muller Stem. The recall was initiated on 28 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 2905496

Quantity recalledN/A

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-1525-2018
FDA event ID: 79677
Recalling firm: Zimmer, Winterthur, N/A
Classification: Class II
Status: Terminated
Recall initiated: 28 Feb 2018
FDA classified: 26 Apr 2018
Reported: 2 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

28 Feb 2018	Recall initiated by company
26 Apr 2018	Classified by FDA	+57 days
2 May 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

A potential commingle that could result in the product in the package not matching the product on the outer label.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496

Where it was distributed

There was no distribution to the US. The distribution occurred to the following countries: Belgium, Switzerland, Germany, France, Canary Islands, Italy, and Thailand.

Questions about this recall

Is Avenir Muller Stem recalled?

Yes. Zimmer recalled Avenir Muller Stem on 28 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1525-2018.

Why was it recalled?

A potential commingle that could result in the product in the package not matching the product on the outer label.

Which lots are affected?

Lot Number: 2905496

Where was it sold?

There was no distribution to the US. The distribution occurred to the following countries: Belgium, Switzerland, Germany, France, Canary Islands, Italy, and Thailand.

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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