FDA-Device2020-04-01Class II
Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.
Biomet, Inc.
Hazard
A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.
Sold states
International distribution in the countries of Canada, Japan, Netherlands, South Korea.
Affected count
14 units
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1543-2020Don't want to check this manually?
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