Device recall

GM Helix Implant, Endosseous Dental Implant Article No. 109.984

FDA recall source

Recall number

Z-2929-2026

Event id

99407

Status

Ongoing

FDA classification

Class II

Recalling firm

Straumann USA LLC

Report date

Aug 19, 2026

Initiated

Jul 13, 2026

Center classification date

Aug 10, 2026

Reason

There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume

Quantity

417 US

Code info

UDI-DI 7899878024552 Lot MVXJ9

Distribution

US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.

Voluntary or mandated

Voluntary: Firm initiated

Location

Andover, MA, United States