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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92867

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

Open FDA event record

Event summary

Timeline bucket
July 18, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Preat Corp

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

3 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 3

Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental

Z-0152-2024
Recall number
Z-0152-2024
Initiated
July 18, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Preat Corp
Quantity
13 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

Code information

UDI-DI: 00842092161364/Lot # OF018356

Distribution pattern

US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None

device · product 2 of 3

Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental

Z-0153-2024
Recall number
Z-0153-2024
Initiated
July 18, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Preat Corp
Quantity
23 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

Code information

UDI-DI: 00842092161388/Lot #OF018357

Distribution pattern

US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None

device · product 3 of 3

Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental

Z-0154-2024
Recall number
Z-0154-2024
Initiated
July 18, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Preat Corp
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

Code information

UDI-DI: 00842092161395/Lot #OF018355

Distribution pattern

US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None

Field note

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