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U.S. Department of Health and Human Services

Class 2 Device Recall Straumann Bone Level Tapered Implants

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 Class 2 Device Recall Straumann Bone Level Tapered Implantssee related information
Date Initiated by FirmJuly 16, 2026
Date PostedAugust 11, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2935-2026
Recall Event ID 99441
510(K)NumberK140878 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductStraumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
Code Information UDI/DI 7630031707055, Lot ZVFV5
FEI Number 1000121052
Recalling Firm/
Manufacturer		 Straumann USA LLC
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information ContactTodd Shevlin
978-759-5442
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionStraumann 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."
Quantity in Commerce175 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DZE
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