FDAFDA · Food and drugs·Recall number Z-1291-2022
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
Published July 6, 2022 · Recall initiated: June 2, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The instrument is incorrectly color coded.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Wright Medical Technology, Inc.
- Distributor
- 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.
- Lot
- Lot #2039558, GTIN 00889797006552.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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