Class IIDeviceOngoing

Straumann USA LLC

GM Helix Implant, REF: 109.984;

Reason for recall

There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.

Details

Recall number: Z-3173-2026
Event ID: 99707
Recall initiated: Aug 12, 2026
Classified: Sep 15, 2026
Reported: Sep 23, 2026
Quantity: 216
Distribution: 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;
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Andover, MA, United States
Lot / code info: REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;