FDA-Device2018-05-02Class II
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
Synthes, Inc.
Hazard
There is a potential for the connection screw of the stem extractor to break.
Sold states
Worldwide Distribution: US (nationwide) and to countries of: Canada and Switzerland.
Affected count
31
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1514-2018Don't want to check this manually?
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