Intersect ENT, Inc. Recall 91063
Description: Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Intersect ENT, Inc. Recall 91063 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0458-2023 |
| Event ID | 91063 |
| Event Description | Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044 |
| Product Type | Devices |
| 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. |
| Quantity | 611 units |
| Recall Reason | Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI. |
| Device Classification | 20221214 |
| Device Code Info | REF: 60044, UDI-DI: M927600440, Lot: 22041901 |
| Center Classification Date | 20221208 |
| Recall Initiation Date | 20221021 |
| Recalling Firm | Intersect ENT, Inc. |
| Initial Notification | Letter |
| Similar To |