Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104…

Recall date
October 10, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0300-2020
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

Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 0104555505 0104555520 0104555525

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