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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94032

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

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Event summary

Timeline bucket
February 09, 2024
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

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

Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967

Z-1321-2024
Recall number
Z-1321-2024
Initiated
February 09, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Preat Corp
Quantity
561 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.

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

Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.

Code information

Model Number: 9000967 UDI-DI code: 00842092165867 Lot Numbers: 235650, 234294, 233667, 233885, 233439, and 231489

Distribution pattern

U.S. Nationwide distribution in the states of AZ, OH and PA.