Official recall notice
FDA DeviceClass IINotable
Straumann Bone Level Tapered Implant Recall (Aug 2026)
Product: Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
- Recall date
- 2026-08-19
- Brand
- Straumann USA LLC
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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 description
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.
Affected products
UDI/DI 7630031707055, Lot ZVFV5