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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97720

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

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Event summary

Timeline bucket
September 30, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Prismatik Dentalcraft, 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

Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117

Z-0417-2026
Recall number
Z-0417-2026
Initiated
September 30, 2025
Classification
Class II
Status
Ongoing
Quantity
208 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect titanium screw, packaged with dental implant.

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

Incorrect titanium screw, packaged with dental implant.

Code information

Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089

Distribution pattern

US Distribution to states of: California, Colorado, Connecticut, Florida, Georgia, Hawaii, Kentucky, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Virginia, Washington.