Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general ort…

Recall date
December 19, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0871-2020
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
US Nationwide and Foreign: countries of Canada, CHINA, NETHERLANDS

Why it was recalled

Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach

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

What was recalled

ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument

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