Exact FDA event identifier

Event 98773

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

Open FDA event record

Event summary

Timeline bucket: April 03, 2026
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Grace Medical, 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

TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis

Z-2308-2026

Recall number: Z-2308-2026
Initiated: April 03, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Grace Medical, Inc.
Quantity: 7

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Due to incorrect functional length on device labeling.

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

Due to incorrect functional length on device labeling.

Code information

Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927

Distribution pattern

U.S Nationwide distribution in the state of MD.