Stryker INFINITY Resect Guide for INBONE Talus recalled over sterility concerns
- Recall date
- June 2, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Wright Medical Technology, Inc. recalls Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFIN…
- Recall number
- Z-1291-2022
- FDA classification
- Class II
- Brand / firm
- Wright Medical Technology, Inc.
- Sold / distributed
- 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.
Why it was recalled
The instrument is incorrectly color coded.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
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