Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331

Recall date
August 6, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0517-2020
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
CA, IN, MN, NJ, NY, AR, LA, OH, KY, TX, CO (US) CA, CN, NL (International)

Why it was recalled

The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331.

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 Biomet¿ Rasp, Model Number 110032331

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