FDA Reports Class II Recall of Straumann Dental Implants Over Mislabeled Length
The FDA has reported a Class II recall of certain Straumann Bone Level Tapered implants that may be shorter than labeled, as of August 19, 2026.
2 reports on this incident · first at Aug 26, 2026, 8:41 p.m. ET
Earlier reports
Aug 26, 2026, 8:41 p.m. ETFirst report
FDA Class II Recall Issued for Straumann Dental Implants Due to Mislabeled Length
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for certain Straumann dental implants, according to an enforcement report dated August 19, 2026. The recall, initiated July 16, 2026, affects 175 units of the Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314), distributed nationwide. The affected units carry UDI/DI 7630031707055 and lot ZVFV5.
The FDA states the implants may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling suggests. The recall is classified as Class II, the FDA's middle category, used where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The recall status is ongoing.
The product is a tapered, screw-shaped dental implant fixture made from a titanium-zirconium alloy, surgically installed into the jawbone to anchor dental prostheses such as crowns, bridges, or dentures, according to product information from fda.gov, i3cglobal.com, straumann.com, and completesmilesbv.com.au. The FDA enforcement database records no other enforcement action by this firm.
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- Version 127 Aug 2026, 00:41current
First published.
- Version 127 Aug 2026, 00:54current
First published.
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