← FDA ENFORCEMENT
Z-1994-2026Class II

Straumann USA LLC

Recalling firm
Straumann USA LLC
Product type
Device
Status
Ongoing
Report date
2026-05-06
Distribution
US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
Firm state
MA
Product quantity
5 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

Includes an incorrect screw seat interface.

Product description

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

Code / lot 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.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.