Z-2263-2020 Class I Terminated
FDA device recall Z-2263-2020 was initiated by Endologix, Inc. on May 6, 2020 and is designated Class I. Reason for recall: A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. … The recall status is terminated (terminated May 3, 2024). Affected quantity: 9156.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- May 6, 2020
- Termination Date
- May 3, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9156
Product Description
Reason for Recall
Distribution Pattern
Worldwide DIstribution: U.S (nationwide).: PA, AZ, NY, FL, HI, CA, OR, IL, MS, AR, WI, KY, TX, TN, MO, NJ, MA, MT, VA, MI, CO, WV, NC, NH, NV, CT, ME, WY, OH, OK, IN, UT, AL, WA, GA, SC, KS, LA, NM, MD, DC, NE, SD, RI, IA, VT, ND. and Countries of:: Argentina, Australia, Chile, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Taiwan, Thailand, Canada, Austria, Belgium, Cyprus, Czech Republic, Germany, Hungary, Ireland, Italy, Switzerland, Luxembourg, Netherlands, Poland, Portugal, Romania, Spain, Sweden, and United Kingdom