Straumann USA LLC Straumann Bone Level Tapered Implant Recall (Unknown Month Year)
Announced 2026-08-19 · FDA
Straumann USA LLC is recalling the Straumann Bone Level Tapered Implant. The recall covers 417 implants distributed nationwide in the US. The issue is a possible mismatch between the implant inside the packaging and the outer carton label, and if the incorrect implant is installed, it could cause bone compression or installation difficulties when there is sufficient bone volume.
| Brand | Straumann USA LLC |
|---|---|
| Product | GM Helix Implant, Endosseous Dental Implant Article No. 109.984 |
| 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 |
| Severity | moderate |
| Units affected | 175 |
| 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. |
| Agency | FDA |
| Recall / campaign no. | UDI-DI 7899878024552 Lot MVXJ9 |
WHAT YOU SHOULD DO
- Do not install or use implants from Lot MVXJ9 or UDI-DI 7899878024552 until cleared.
- Check packaging and outer carton labels to verify the correct implant; do not rely on the carton label alone.
- Contact Straumann USA or your dental professional for replacement, exchange, or return instructions per FDA recall guidance.
- If you have already undergone a procedure or have concerns, consult your dentist promptly.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.