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Intersect ENT, Inc. Recall 91063

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

Intersect ENT, Inc. Recall 91063 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0458-2023
Event ID91063
Event DescriptionPropel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Product TypeDevices
DistributionUS 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.
Quantity611 units
Recall ReasonSinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
Device Classification20221214
Device Code InfoREF: 60044, UDI-DI: M927600440, Lot: 22041901
Center Classification Date20221208
Recall Initiation Date20221021
Recalling FirmIntersect ENT, Inc.
Initial Notification Letter
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