- Recalling firm
- Straumann USA LLC
- Reason for recall
- Includes an incorrect screw seat interface.
- Affected products (lot / model / serial)
- 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.
- Units affected
- 5 units
- Distribution pattern
- US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
- Firm location
- Andover, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1994-2026
- Recall initiated
- March 27, 2026
- FDA classification date
- April 29, 2026
- FDA report date
- May 6, 2026
- FDA event ID
- 98681
- Last updated on HTM Vibe
- July 24, 2026