GM Helix Implant recall (Straumann USA LLC)
Medical deviceClass IIOngoing
Summary: Straumann USA LLC is recalling GM Helix Implant, REF: 109.984;. Reason: There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
What is being recalled
GM Helix Implant, REF: 109.984;
Why
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
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 in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, WI; (states named: 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)
How to tell if yours is affected
REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;
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-3173-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 12, 2026 |
| Reported | September 23, 2026 |
| Company | Straumann USA LLC |
| Company location | Andover, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 216 |
More recalls from Straumann USA LLC · all medical device recalls · recalls from August 2026