Exact FDA event identifier

Event 91527

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

Open FDA event record

Event summary

Timeline bucket: January 13, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Summit Medical, LLC

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

Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.

Z-1171-2023

Recall number: Z-1171-2023
Initiated: January 13, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Summit Medical, LLC
Quantity: 30 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Sterile product pouches were not sealed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile product pouches were not sealed.

Code information

Lot #219349, Exp. 2027-11-01, UDI (01)00385640065214(17)271101(10)219340

Distribution pattern

US Distribution was made to CO, FL, GA, LA, MA, and ME. There was no government/military distribution. OUS Foreign distribution was made to Canada.