Device recall

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

FDA recall source

Recall number

Z-2935-2026

Event id

99441

Status

Ongoing

FDA classification

Class II

Recalling firm

Straumann USA LLC

Report date

Aug 19, 2026

Initiated

Jul 16, 2026

Center classification date

Aug 11, 2026

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.

Quantity

175 units

Code info

UDI/DI 7630031707055, Lot ZVFV5

Distribution

US Nationwide distribution.

Voluntary or mandated

Voluntary: Firm initiated

Location

Andover, MA, United States