FDA Device recall Z-2935-2026
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314)
- FDA Device
- Class II
- ongoing
- Published 2026-08-19
On 2026-08-19 the FDA classified a Class II recall of Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314) by Straumann Usa, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2935-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-16 |
| Published | 2026-08-19 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Straumann Usa |
| Distribution | US |
Product
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
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.
Identifiers
| code_info | UDI/DI 7630031707055, Lot ZVFV5 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2935-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.