Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Reported: December 14, 2022 Initiated: October 21, 2022 #Z-0458-2023
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.
Details
- Recalling Firm
- Intersect ENT, Inc.
- Units Affected
- 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.
- Location
- Menlo Park, CA
Frequently Asked Questions
What product was recalled? ▼
Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044. Recalled by Intersect ENT, Inc.. Units affected: 611 units.
Why was this product recalled? ▼
Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 14, 2022. Severity: Moderate. Recall number: Z-0458-2023.
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