FDAClass II · Medical device · Recall Z-1994-2026 · Recalled May 6, 2026

Straumann n!ce PMMA Full-arch Restoration recall — Straumann USA LLC

Agency report date: May 6, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Straumann n!ce PMMA Full-arch Restoration
Company / brand: Straumann USA
Lot / serial / date codes: Article 010.0304. UDI: (01)07630031779977(11)YYMMDD(10)XXXXX. Project Numbers: 28000US_00811_00_b00, 28000US_00811_01_b00, 28000US_00426_00_b00, 28000US_00449_00_b00, 28000US_01266_00_b00.
Distribution: US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.

Agency product description and boundaries

Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Includes an incorrect screw seat interface.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Straumann n!ce PMMA Full-arch Restoration

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1994-2026
Brand: Straumann USA
Classification: Class II
Units affected: 5 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Straumann n!ce PMMA Full-arch Restoration

Companies & origin

Recalling firm location: Andover, MA, United States
Firm address: 60 Minuteman Rd, 01810-1008

Identifying details (verbatim from the notice)

Product codes / lots: Article 010.0304. UDI: (01)07630031779977(11)YYMMDD(10)XXXXX. Project Numbers: 28000US_00811_00_b00, 28000US_00811_01_b00, 28000US_00426_00_b00, 28000US_00449_00_b00, 28000US_01266_00_b00.
Distribution: US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
Firm notified the public via: Letter
FDA event ID: 98681
Recall initiated: March 27, 2026
FDA classified: April 29, 2026
FDA report date: May 6, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved August 4, 2026 at 11:00 PM UTC.

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