Class II — Straumann USA LLC
| Recalling firm | Straumann USA LLC |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form |
| Quantity | 175 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2026-07-16 |
| Classified | 2026-08-11 |
| Recall number | Z-2935-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Straumann USA LLC (Z-2935-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99441/
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