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STRAUMANN BONE LEVEL TAPERED IMPLANT recallZ-2935-2026 · Straumann USA LLC · initiated Jul 16, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Straumann USA LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

Straumann Group issued an Urgent Field Safety Action notice to its consignees on 7/16/2026 via UPS. The notice explained the issue, potential risk, and requested the following: "Action to be taken: 1. Identify and segregate any units in your stock with carton packaging labelled as Article 021.5314 Bone Level Tapered Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim" (Article 021.5314, Lot ZVFV5) 2. Return any segregated units with carton packaging labelled as Article 021.5314 Bone Level Tapered Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim", Lot ZVFV5 for replacement or refund 3. If the product has been implanted with no unexpected clinical occurrence during implantation, then no special follow up outside of the dentist s standard follow procedure is necessary 4. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided to: Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 If product is not being returned, the completed Customer Confirmation Form can be scanned and emailed to [email protected] Transmission of the Field Safety Notice This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred."

Recall details

Recall number
Z-2935-2026
Status
Open, Classified
Initiated by the company
Jul 16, 2026
Posted by the FDA
Aug 11, 2026
Recalling firm
Straumann USA LLC
Quantity
175 units
Product code
DZE
FDA submissions
K140878
Distribution
US Nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

UDI/DI 7630031707055, Lot ZVFV5

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

38 devices cleared under K140878 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page