Medical device recalls Moderate risk

Synthes, Inc. recalls Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder impla…

Recall date
March 19, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1514-2018
FDA classification
Class II
Brand / firm
Synthes, Inc.
Sold / distributed
Worldwide Distribution: US (nationwide) and to countries of: Canada and Switzerland.

Why it was recalled

There is a potential for the connection screw of the stem extractor to break.

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

What was recalled

Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.

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