Medical device recalls Moderate risk

Zimmer GmbH recalls Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368

Recall date
February 28, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1524-2018
FDA classification
Class II
Brand / firm
Zimmer GmbH
Sold / distributed
There was no distribution to the US. The distribution occurred to the following countries: Belgium, Switzerland, Germany, France, Canary Islands, Italy, and Thailand.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368

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