Z-2935-2026 Class II Ongoing
FDA device recall Z-2935-2026 was initiated by Straumann USA LLC on July 16, 2026 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 175 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2026
- Initiation Date
- July 16, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 175 units
Product Description
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI/DI 7630031707055, Lot ZVFV5