FDA-Device2022-07-06Class II
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
Wright Medical Technology, Inc.
Hazard
The instrument is incorrectly color coded.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL, MA, MI, MN, MO, NC, NY, OH, PA, TX, and WA. The countries of Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Sweden, Switzerland, and United Kingdom.
Affected count
35 units
Manufactured in
1023 Cherry Rd, Memphis, TN, United States
Products
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1291-2022Don't want to check this manually?
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