Straumann USA Llc: Implant, Endosseous, Root-form

Recall Summary Straumann USA is recalling certain Bone Level Tapered dental implants (4.1mm diameter, 14mm length, SLActive surface) because some packages may contain 12mm implants instead of the labeled 14mm length. The affected implants were distributed nationwide across all U.S. states and Washington, D.C.

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
Reason
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.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-07-16
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide distribution.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/378b5ce8-9591-4750-ad25-4ca8493205e4