FDA recall, , Moderate risk
Straumann GM Helix Dental Implants
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label.
Summary by Recall Canary from the FDA notice
What happened
Straumann USA LLC, of Andover, Massachusetts, began a recall on July 13, 2026, of the GM Helix Implant, Endosseous Dental Implant Article No. 109.984, because there may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label.
The issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume.
The recall involves 417 units distributed nationwide, including in 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 and Wisconsin.
The FDA added the recall to its Enforcement Report on August 10, 2026, and it was in the FDA's weekly enforcement report on August 19, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
- UDI-DI
- 7899878024552
- Lot code
- MVXJ9
Recall details
- Company began the recall
- Sold in
US Nationwide distribution including in the states of 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.
- Company
- Straumann USA LLCAndover, Massachusetts
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99407
- Recall number
- Z-2929-2026
- Quantity recalled
- 417 US
All recalls from Straumann USA LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
