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GM Helix Implant, Endosseous Dental Implant Article No. 109.984

Class II
Recalling firm
Straumann USA LLC
Reason for recall
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
Affected products (lot / model / serial)
UDI-DI 7899878024552 Lot MVXJ9
Units affected
417 US
Distribution pattern
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.
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-2929-2026
Recall initiated
July 13, 2026
FDA classification date
August 10, 2026
FDA report date
August 19, 2026
FDA event ID
99407
Last updated on HTM Vibe
August 26, 2026
View on openFDA