Z-1291-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2022
- Initiation Date
- June 2, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 units
Product Description
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
Reason for Recall
The instrument is incorrectly color coded.
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.
Code Information
Lot #2039558, GTIN 00889797006552.