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

FDA device recall Z-2935-2026 · posted 2026-08-11 · Open, Classified

Recall details

Recalling firm

Straumann USA LLC

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.

Action taken

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 todd.shevlin@straumann.com 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."

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DZE

Quantity affected

175 units

Distribution

US Nationwide distribution.

Date initiated

2026-07-16

Date posted

2026-08-11

Location

Andover, MA

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