Reported Dec 26, 2018 · Terminated

Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller…

Zimmer GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer GmbH · Sulzerallee 8 · Winterthur · N/A

Is this the product you have?

  • Avenir¿ Muller Stem Standard, uncemented HA, 1
  • Taper 12/14 Item Number01.06010.001 -
  • Product UsageAvenir@ 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
Lot codes and dates
  • Lot Number2955599
  • UDI Number(01) 00889024479456(17)230831(10)2955599
Amount recalled
13 units

Why it was recalled

Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 1, 2020 · Data as of Sep 19, 5:34 PM UTC

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