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Device Class II · moderate Ongoing

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

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.

Recalling firmStraumann USA LLC
ReasonBone 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.
Risk classClass II (Class II · moderate)
StatusOngoing
Report dateAug 19, 2026
InitiatedJul 16, 2026
RegionMA, United States
DistributionUS Nationwide distribution.
Quantity175 units
Code/LotUDI/DI 7630031707055, Lot ZVFV5
TypeVoluntary: Firm initiated
Recall numberZ-2935-2026

Official source

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openFDA (U.S. Food & Drug Administration) — food/drug/device enforcement · CC0 1.0 (public domain)

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