⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

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

Medical DevicesSource: FDA (device) · Date: 2026-08-19

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Straumann USA LLC
Product
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2026-07-16
Code info
UDI/DI 7630031707055, Lot ZVFV5
Product quantity
175 units
Voluntary mandated
Voluntary: Firm initiated
City
Andover
State
MA
Country
United States
Event id
99441
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