- Recalling firm
- Straumann USA LLC
- Reason for recall
- There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
- Affected products (lot / model / serial)
- REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;
- Units affected
- 216
- Distribution pattern
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, WI;
- 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-3173-2026
- Recall initiated
- August 12, 2026
- FDA classification date
- September 15, 2026
- FDA report date
- September 23, 2026
- FDA event ID
- 99707
- Last updated on HTM Vibe
- September 29, 2026