Z-2935-2026Class II

Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314)...

Name: Z-2935-2026 Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314)...
Creator: Straumann USA LLC
Published: 2026-07-16
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2026-07-16 / Open, Classified / root cause: labeling and UDI

FDA source

Straumann USA LLC began a recall of Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form on 2026-07-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2935-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-16
Posted: 2026-08-11
Recalling firm: Straumann USA, LLC
Product: Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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."
Quantity in commerce: 175 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI 7630031707055, Lot ZVFV5

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2935-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2935-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-11

Product code DZE

K140878Class IIStraumann Bone Level Tapered ImplantStraumann USA, LLC / cleared 2014-08-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)