Recall Z-3173-2026 ยท DZE Implant, Endosseous, Root-Form
Straumann USA LLC
GM Helix Implant, REF: 109.984;
| Date | Sep 15, 2026 (initiated Aug 12, 2026) |
| Status | Open, Classified |
| Reason | There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside. |
| Root cause | Under Investigation by firm |
| Action | On August 12, 2026, Urgent Field Safety Action letters were sent to customers. Actions to be taken: 1. Identify and segregate any units in your stock with carton packaging labeled as Article 109.984 Helix GM Implant, 4.0 x 11.5 mm, L ot VZPF4 2. If the article is still in your inventory, then stop use/ distribution of the product immediately and quarantine / segregate physically. 3. Please return the affected items to the attention of Todd Shevlin at Straumann USA, LLC for replacement as indicated on the Customer Confirmation Form. 4. If the product has already been implanted, implant remova |
| 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; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163194 | Neodent Implant System - GM Line Jjgc Industria E Comercio DE Materiais Dentarios S.A., Jul 14, 2017 |