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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83198

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

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Event summary

Timeline bucket
May 30, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Paltop Advanced Dental Solutions Ltd

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

Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

Z-0019-2020
Recall number
Z-0019-2020
Initiated
May 30, 2019
Classification
Class II
Status
Terminated
Quantity
167 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

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Inspect official wording and provenance

Reason for recall

Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant.

Code information

Lot Number: W0-008254 UDI: 729010869611020-70024P

Distribution pattern

AL AZ CA CO FL GA MA MD MO MT NJ NM NY OH SC VA