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U.S. Department of Health and Human Services

Class 2 Device Recall Propel Mini Mometasone Sinus Implant

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  Class 2 Device Recall Propel Mini Mometasone Sinus Implant see related information
Date Initiated by Firm October 21, 2022
Date Posted December 08, 2022
Recall Status1 Open3, Classified
Recall Number Z-0458-2023
Recall Event ID 91063
Product Classification Drug-eluting sinus stent - Product Code OWO
Product Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Code Information REF: 60044, UDI-DI: M927600440, Lot: 22041901
Recalling Firm/
Manufacturer		 Intersect ENT, Inc.
1555 Adams Dr
Menlo Park CA 94025-1439
For Additional Information Contact Brett Cromwell
650-641-2115
Manufacturer Reason
for Recall		 Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
FDA Determined
Cause 2		 Error in labeling
Action On 10/21/22, recall notices from Medtronic/Intersect ENT were sent to customers who were asked to do the following: 1) Identify, quarantine, and return all unused affected products to Medtronic. 2) Complete and return the customer confirmation form. 3) Distribute the recall notice to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. The following contact information was provided: rs.xentproductfeedback@medtronic.com and CustomerService@intersectent.com
Quantity in Commerce 611 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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