FDAFDA recall Z-3173-2026 · Sep 23, 2026
Straumann USA LLC: GM Helix Implant recall
Recall found
Product
GM Helix Implant, REF: 109.984;
Reason for recall
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
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
- REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;
- Quantity
- 216
- Distribution
- 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;
- Recalling firm
- Straumann USA LLC, Andover, MA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-12
Source: openFDA enforcement record Z-3173-2026 · search recall number Z-3173-2026 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.