Class IIOngoingZ-3173-2026
Straumann USA LLC recalls GM Helix Implant
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
Straumann USA LLCMASep 23, 2026
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–2 of 2 recalls
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.