GM Helix Implant recall
Straumann USA LLC recalled GM Helix Implant on August 19, 2026 because of there may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. It was sold nationwide.
Why it was recalled
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
What's recalled
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Quantity: 417 US
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Straumann USA LLC, Andover, MA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
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. - Status
- Ongoing
- Recall number
- Z-2929-2026
- Source
- U.S. Food and Drug Administration
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