Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.

Recall date
June 8, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2820-2018
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
US distribution to CA, GA, IL, MO, NY, and VA.

Why it was recalled

Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.

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

What was recalled

ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.

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