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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96047

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

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Event summary

Timeline bucket
January 10, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Nobel Biocare

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

. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function

Z-1101-2025
Recall number
Z-1101-2025
Initiated
January 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Nobel Biocare
Quantity
1,558 units (90 units - U.S.)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.

Code information

Nobel Biocare N1 TiUltra TCC RP 4.0x 9mm Catalog Number: 300861 UDI-DI code: 07332747161731 Lot Numbers: 12253672 12253673 Nobel Biocare N1 TiUltra TCC RP 4.0x11mm Catalog Number: 300862 UDI-DI code: 07332747161748 Lot Numbers: 12253448 12254209 Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Catalog Number: 300863 UDI-DI code: 07332747161755 Lot Numbers: 12253620 12254213

Distribution pattern

U.S. Nationwide distribution in the states of CA, FL, IL, MA, NJ, NY, OH, PA, UT, VA and WA.