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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