Device product
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
Z-1291-2022
Product summary
- Event
- Event 90216
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 35 units
- Official record key
device-enforcement:Z-1291-2022
Official wording
Reason: The instrument is incorrectly color coded.
Code information: Lot #2039558, GTIN 00889797006552.
Distribution pattern: 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.
Derived failure modes
-
Unknown
The instrument is incorrectly color coded.