Straumann GM Helix Implant
The GM Helix Implant has a discrepancy between its packaging identification and the dimensions of the implant inside.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Straumann USA LLC of Andover, Massachusetts, began a recall of the GM Helix Implant, REF: 109.984, on August 12, 2026, because there is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside. The recall was added to the FDA's Enforcement Report on September 15, 2026, and was in the FDA's weekly enforcement report on September 23, 2026. The product was distributed nationwide in the United States.
Summary by Recall Canary from the FDA notice.
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, lot code and reference number listed under your product.
GM Helix Implant
- UDI-DI
- 7899878024552
- Reference number
- 109.984
- Lot
- VZPF4
Details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Wisconsin;
- Event ID
- 99707
- Recall No.
- Z-3173-2026
- Company
- Straumann USA LLCAndover, Massachusetts
- Hazard
- Device defect
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
