Straumann USA LLC recalls GM Helix Implant

There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.

On August 12, 2026, Urgent Field Safety Action letters were sent to customers. Actions to be taken: 1. Identify and segregate any units in your stock with carton packaging labeled as Article 109.984 Helix GM Implant, 4.0 x 11.5 mm, L ot VZPF4 2. If the article is still in your inventory, then stop use/ distribution of the product immediately and quarantine / segregate physically. 3. Please return the affected items to the attention of Todd Shevlin at Straumann USA, LLC for replacement as indicated on the Customer Confirmation Form. 4. If the product has already been implanted, implant removal is not required, and no additional patient follow -up is required solely due to this recall 5. 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. If product is not being returned, the completed Customer Confirmation Form can be scanned and emailed to todd.shevlin@straumann.com

• FDA enforcement recordOfficial FDA database entry for Z-3173-2026
• FDA 510(k) clearance · K163194The device's official FDA premarket clearance record
• FDA device classification · DZEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 872.3640The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Straumann USA LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.