Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2935-2026·Announced 2026-08-19

Straumann BLT Dental Implant Recall Due to Incorrect Length Labeling

Straumann USA LLC is recalling 175 units of BLT dental implants that may be 12mm instead of the labeled 14mm length.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.

Plain-English summary

Straumann USA LLC is recalling 175 units of Straumann Bone Level Tapered (BLT) Implants, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314). The recall is due to a labeling error where the implants may inadvertently be 12mm in length instead of the 14mm length indicated on the labeling.

The affected product is identified by UDI/DI 7630031707055 and Lot ZVFV5. The products were distributed nationwide in the United States. This is a Class II recall, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare professionals and patients should check their inventory and records for the specific lot number and UDI/DI listed above. If the product is found, it should be removed from use and returned to the manufacturer or their authorized representative. No specific instructions for patient management are provided in the source text.

The recalled product

Product: Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
Manufacturer: Straumann USA LLC
Category: Medical Device — Dental Implant
Hazard: mis-labeling
Affected units: 175

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

UDI/DI 7630031707055
Lot ZVFV5

Distribution

Distributed nationwide across the United States.

Same manufacturer · Straumann USA LLC

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