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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85530

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

Open FDA event record

Event summary

Timeline bucket
May 28, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Nobel Biocare Usa 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

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

Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.

Z-2250-2020
Recall number
Z-2250-2020
Initiated
May 28, 2019
Classification
Class II
Status
Terminated
Recalling firm
Nobel Biocare Usa Llc
Quantity
234 pieces globally, of which 16 were sent to the US.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Packaged dental implant healing abutments were found to contain the wrong size device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaged dental implant healing abutments were found to contain the wrong size device.

Code information

Lot 13076845

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of TN, IL, MI, and NY. The countries of AT, RU, BE, DE, GB, NO, PL, PT.