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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91601

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

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Event summary

Timeline bucket
January 20, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Coltene Whaledent 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

SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001

Z-1208-2023
Recall number
Z-1208-2023
Initiated
January 20, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Coltene Whaledent Inc
Quantity
3896 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button

Code information

UDI-DI: +ESANS100010 All Serial Numbers

Distribution pattern

Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey