Recall Z-0458-2023— Intersect ENT, Inc.
Class II · Ongoing
Class II FDA medical device recall by Intersect ENT, Inc., initiated 2022-10-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044. Reason: Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI..
- Recalling firm
- Intersect ENT, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-10-21
- Firm location
- Menlo Park, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.