FDAFDA recall Z-2935-2026 · Aug 19, 2026
Straumann USA LLC: Straumann Bone Level Tapered (BLT) Implant recall
Recall found
Product
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI/DI 7630031707055, Lot ZVFV5
- Quantity
- 175 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Straumann USA LLC, Andover, MA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-16
Source: openFDA enforcement record Z-2935-2026 · search recall number Z-2935-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.