GM Helix Implant recall (Straumann USA LLC)
Medical deviceClass IIOngoing
Summary: Straumann USA LLC is recalling GM Helix Implant, Endosseous Dental Implant Article No. 109.984. 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.
What is being recalled
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Why
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
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin)
How to tell if yours is affected
UDI-DI 7899878024552 Lot MVXJ9
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2929-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 13, 2026 |
| Reported | August 19, 2026 |
| Company | Straumann USA LLC |
| Company location | Andover, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 417 US |
More recalls from Straumann USA LLC · all medical device recalls · recalls from July 2026