Z-0341-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 7, 2018
- Initiation Date
- September 25, 2018
- Termination Date
- June 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9834 total
Product Description
Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
Reason for Recall
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
Distribution Pattern
US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
Code Information
GPN: G36233