Recall Z-2935-2026 ยท DZE Implant, Endosseous, Root-Form
Straumann USA LLC
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
| Date | Aug 11, 2026 (initiated Jul 16, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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 t |
| Quantity | 175 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140878 | STRAUMANN BONE LEVEL TAPERED IMPLANT Straumann USA, LLC, Aug 20, 2014 |