Device product
Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Z-0458-2023
Product summary
- Event
- Event 91063
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 611 units
- Official record key
device-enforcement:Z-0458-2023
Official wording
Reason: Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
Code information: REF: 60044, UDI-DI: M927600440, Lot: 22041901
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
label displays incorrect