Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430…

Recall date
October 10, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0298-2020
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
Distributed nationwide.

Why it was recalled

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

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

What was recalled

BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 00430001217 00430001220 00430001313 00430001413 00430001417 00430001420 00430001513 00430001613 00430001713 00430001813 47430103100

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