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Intersect ENT, Inc. recalls Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Recalled December 14, 2022 · FDA recall Z-0458-2023 · Intersect ENT
Hazard
Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI. · FDA Class II
Units
611 units
Sold at
US Nationwide distribution including in the states of NC, IL, KS, OR, WI, TX, FL, MN, WY, UT, NY, CA, NJ, OK, MD, HI, MT, TN, MO, IA, MA, AZ, GA, LA, ID, SC, WA, SD, ND, CO, NV.
Description
Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
Product
Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Manufacturer(s)
Intersect ENT, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →