FDA Medical devices recall ·
GM Helix Implant recall
- Recall number
- Z-3173-2026
- Date
- (initiated August 12, 2026)
- Company / brand
- Straumann USA LLC
60 Minuteman Rd, Andover, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 216
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GM Helix Implant, REF: 109.984;
Why was it recalled?
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;
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;
States: 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
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3173-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.