| | Class 2 Device Recall Propel Mini Mometasone Sinus Implant |  |
| Date Initiated by Firm | October 21, 2022 |
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| Date Posted | December 08, 2022 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0458-2023 |
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| Recall Event ID |
91063 |
| Product Classification |
Drug-eluting sinus stent - Product Code OWO
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| Product | Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044 |
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| Code Information |
REF: 60044, UDI-DI: M927600440, Lot: 22041901 |
| FEI Number |
3008301917
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Recalling Firm/
Manufacturer |
Intersect ENT, Inc.
1555 Adams Dr
Menlo Park
CA
94025-1439
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| For Additional Information Contact | Brett Cromwell
650-641-2115 |
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Manufacturer Reason
for Recall | Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI. |
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FDA Determined
Cause 2 | Error in labeling |
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| 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 |
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| Quantity in Commerce | 611 units |
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| 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.
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| Total Product Life Cycle | TPLC Device Report |
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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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