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Straumann Bone Level Tapered Implant
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MEDICAL DEVICE RECALLMODERATE

Straumann Bone Level Tapered Implant

Straumann recalls BLT Implant D 4.1mm RC SLActive 14mm due to possible 12mm length mismatch.

What to do

Contact Straumann USA LLC to determine if your implant is affected and to arrange for return or replacement.

Recalled
Listed
Updated
Recall No.
Z-2935-2026
Agency
FDA
Firm
Straumann USA LLC
Recall ID
99441
Status
ONGOING

Recall at a glance

Quantity recalled
175 units

Why it was recalled

Straumann USA LLC is recalling the Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314) because some implants may be 12mm in length instead of the labeled 14mm.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

Lot code
ZVFV5
UDI-DI
7630031707055

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other Labeling Error recalls

Other recent recalls from Straumann USA LLC

All recalls from Straumann USA LLC

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Editorial summary by Recall Canary · summary updated 2026-08-12 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification