Recall Z-2929-2026 ยท NHA Abutment, Implant, Dental, Endosseous
Straumann USA LLC
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
| Date | Aug 10, 2026 (initiated Jul 13, 2026) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | On July 13, 2026, the firm began notifying customers through a combination of mail, phone, and email. Letters were sent via overnight UPS delivery. Customers were instructed to check their inventory for the affected article/project numbers. If the product is still in inventory, customer should stop use or distribution immediately and quarantine/segregate physically. Product should be returned to Straumann USA, LLC for replacement. If the product has already been implanted, the firm states that implant removal is not required, and no additional patient follow up is required solely due to thi |
| 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. |
| 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 |