Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
Check against the official notice below — it lists the full affected range.
Wright Medical Technology, Inc. is recalling the Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254 (a non-sterile surgical instrument used with the INFINITY Total Ankle System) because the instrument is incorrectly color coded. A total of 35 units were affected, identified by Lot #2039558 and GTIN 00889797006552.
The recalled instrument was distributed worldwide, including across 18 U.S. states (Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Pennsylvania, Texas, and Washington) and 10 countries (Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Sweden, Switzerland, and United Kingdom). The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The instrument is incorrectly color coded.
Reason for recall: The instrument is incorrectly color coded. Distribution: 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. Quantity: 35 units Lot/code info: Lot #2039558, GTIN 00889797006552.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.