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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81456

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

Open FDA event record

Event summary

Timeline bucket
October 02, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Straumann Manufacturing, 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

Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244

Z-0455-2019
Recall number
Z-0455-2019
Initiated
October 02, 2018
Classification
Class II
Status
Terminated
Quantity
21 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Laser engraved label does not match with the item in the package

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Laser engraved label does not match with the item in the package

Code information

Lot Number: 800327510 UDI: (01)07899878026488(11)171110(17)221110(10)800327510

Distribution pattern

US nationwide distribution in the states of GA, TX , VA.