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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91063

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 21, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Intersect ENT, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0458-2023
Recall number
Z-0458-2023
Initiated
October 21, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Intersect ENT, Inc.
Quantity
611 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label displays incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

REF: 60044, UDI-DI: M927600440, Lot: 22041901

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.

Field note

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