FDA recall, , Moderate risk
Straumann Bone Level Tapered (BLT) Implant
The Straumann Bone Level Tapered Implant may contain implants that are 12mm instead of 14mm.
Summary by Recall Canary from the FDA notice
What happened
Straumann USA LLC of Andover, Massachusetts, recalled 175 units of the Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314) because the implants may inadvertently be 12mm in length instead of 14mm as the labeling suggests. The recall began July 16, 2026, and was added to the FDA's Enforcement Report on August 11, 2026.
The product, an endosseous root-form implant, was distributed nationwide in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
- UDI-DI
- 7630031707055
- Lot code
- ZVFV5
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Straumann USA LLCAndover, Massachusetts
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99441
- Recall number
- Z-2935-2026
- Quantity recalled
- 175 units
All recalls from Straumann USA LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
