FDA recall Z-0458-2023

Product

Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044

Reason for recall

Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2022-10-21

Report date

2022-12-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Menlo Park, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0458-2023