Straumann Bone Level Tapered — Class II medical device recall Z-2935-2026
Ongoing recall by Straumann USA LLC, reported 2026-08-19, distributed nationwide. Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants
| Recall number | Z-2935-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Straumann USA LLC, Andover, MA, United States |
| Recall initiated | 2026-07-16 |
| Classified | 2026-08-11 |
| Reported by FDA | 2026-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 175 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07630031707055 |
| Lot numbers | ZVFV5 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2935-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.