FDAFDA recall Z-2929-2026 · Aug 19, 2026
Straumann USA LLC: GM Helix Implant recall
Recall found
Product
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Reason for recall
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 to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI 7899878024552 Lot MVXJ9
- Quantity
- 417 US
- Distribution
- 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.
- Recalling firm
- Straumann USA LLC, Andover, MA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-13
Source: openFDA enforcement record Z-2929-2026 · search recall number Z-2929-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.