Home / Recalls / Intersect ENT, Inc. / Z-0458-2023

Z-0458-2023 Class II Ongoing

Recalled by Intersect ENT, Inc. — Menlo Park, CA

FDA device recall Z-0458-2023 was initiated by Intersect ENT, Inc. on October 21, 2022 and is designated Class II. Reason for recall: Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI. The recall status is ongoing. Affected quantity: 611 units.

Recall Details

Product Type: Devices
Report Date: December 14, 2022
Initiation Date: October 21, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 611 units

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.

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.

Code Information

REF: 60044, UDI-DI: M927600440, Lot: 22041901