Straumann USA LLC recalls Straumann Bone Level Tapered (BLT) Implant

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.

Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form

Straumann Group issued an Urgent Field Safety Action notice to its consignees on 7/16/2026 via UPS. The notice explained the issue, potential risk, and requested the following: "Action to be taken: 1. Identify and segregate any units in your stock with carton packaging labelled as Article 021.5314 Bone Level Tapered Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim" (Article 021.5314, Lot ZVFV5) 2. Return any segregated units with carton packaging labelled as Article 021.5314 Bone Level Tapered Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim", Lot ZVFV5 for replacement or refund 3. If the product has been implanted with no unexpected clinical occurrence during implantation, then no special follow up outside of the dentist s standard follow procedure is necessary 4. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided to: Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 If product is not being returned, the completed Customer Confirmation Form can be scanned and emailed to todd.shevlin@straumann.com Transmission of the Field Safety Notice This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred."

• FDA enforcement recordOfficial FDA database entry for Z-2935-2026
• FDA 510(k) clearance · K140878The device's official FDA premarket clearance record
• FDA device classification · DZEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 872.3640The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Straumann USA LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.