Straumann recalls

Straumann USA LLC is recalling the GM Helix Implant (REF 109.984) because the product label on the packaging does not match the actual dimensions of the implant inside. This mismatch could lead to use of an incorrect implant size during dental procedures. The affected lot (VZPF4) was distributed nationwide to dental providers.

Moderate·FDA·Sep 23, 2026

Straumann USA is recalling one lot of its Bone Level Tapered (BLT) dental implants, 14mm model, because some may actually be 12mm long, which does not match the label. The recall covers 175 units distributed nationwide, and no injuries have been reported.

Moderate·FDA·Aug 19, 2026

Straumann USA is recalling certain GM Helix dental implants (Article No. 109.984, Lot MVXJ9) because the implant inside the package may not match the outer carton label. If the wrong implant is placed, it could cause bone compression or make installation difficult where there is sufficient bone. No injuries have been reported.

Moderate·FDA·Aug 19, 2026

Straumann is recalling two custom abutment products, 20 units in total, for dental implant use. A raw material bar of TAN material was mislabeled as titanium Grade 4, so some RC Titanium abutments were made from the wrong material. The affected units were distributed in several U.S. states and in Canada. No injuries have been reported.

Moderate·FDA·Apr 1, 20262 products

Straumann USA LLC recalled certain WB Impression Post Closed Tray kits because they contain magenta impression caps instead of the correct brown caps. This mix-up could lead to using the wrong component during dental implant procedures. The recall affects 561 units distributed nationwide.

Moderate·FDA·Feb 18, 2026

The possibility for this product that is intended for demonstration purposes only to be placed in patients.

FDA·Dec 3, 2025