Z-0228-2020 Class II Terminated
FDA device recall Z-0228-2020 was initiated by Stryker Neurovascular on Jun 8, 2018 and is designated Class II. Reason for recall: The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is… The recall status is terminated (terminated Apr 28, 2021). Affected quantity: 107.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 6, 2019
- Initiation Date
- Jun 8, 2018
- Termination Date
- Apr 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 107
Product Description
Reason for Recall
Distribution Pattern
Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0228-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026