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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94175

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 04, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
X-NAV Technologies, 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

2 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 2

X-Guide Handpiece Adaptor Sleeve 1, Model P010701

Z-1392-2024
Recall number
Z-1392-2024
Initiated
March 04, 2024
Classification
Class II
Status
Ongoing
Recalling firm
X-NAV Technologies, LLC
Quantity
88 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.

Code information

UDI-DI: 00817421021480; Lot: 2308010012

Distribution pattern

Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.

device · product 2 of 2

X-Guide Handpiece Adaptor Sleeve 3, Model P010727

Z-1393-2024
Recall number
Z-1393-2024
Initiated
March 04, 2024
Classification
Class II
Status
Ongoing
Recalling firm
X-NAV Technologies, LLC
Quantity
154 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.

Code information

UDI-DI: 00817421021503; Lot: 2306020012, 2310010012

Distribution pattern

Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.