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Open, Classified

Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044

FDA Recall Z-0458-2023 · Posted 2022-12-08

Recalling FirmIntersect ENT, Inc.
Recall StatusOpen, Classified
Product CodeOWO
Date Initiated2022-10-21
Product Quantity611 units

Reason for Recall

Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.

Firm 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: [email protected] and [email protected]

Root Cause

Error in labeling

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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