FDA-Device2016-05-11Class II
Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Applied Medical Technology Inc
Hazard
The firm received a complaint of an open pouch which breaches the sterilization validation.
Sold states
Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.
Affected count
1,100 units
Manufactured in
8000 Katherine Blvd, Brecksville, OH, United States
Products
Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1611-2016Don't want to check this manually?
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