medical MODERATE Updated 2026-05-06

Straumann USA LLC recalls Straumann n!ce PMMA Full-arch Restoration. Screw-retained Br

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Recalled Product

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

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Hazard / Issue

Includes an incorrect screw seat interface.

Issued by

FDA

Affected States: AL, AZ, FL, HI, LA, MD, OH, VA
Lot/Code Info: 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.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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