Straumann USA LLC recalls GM Helix Acqua Implant

It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.

GM Helix Acqua Implant, Article Number: 140.985

On May 1, 2025 URGENT FIELD SAFETY ACTION letters were sent to customers. Action to be taken: 1. If article 140.984 Lot JPZ21 or 109.985 Lot JPZ75 are still in your inventory, then stop use/distribution of the product immediately and quarantine/segregate physically. 2. If the product was used and no complications or problems were identified, of the patient did not present symptoms there is no need for any additional action with the patient. 3. If article 140.984 Lot JPZ21 or 109.985 Lot JPZ75 are still in your inventory, return it for a credit or replacement as indicated on the Customer Confirmation Form. 4. In the product is not found in your stock, indicate this on the enclosed Customer Confirmation Form. 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; 60 Minuteman Road, Andover, MA 01810. 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. The FDA has been informed about this Field Safety Corrective Action. We apologize for any inconvenience that this may cause.

• FDA enforcement recordOfficial FDA database entry for Z-1863-2025
• 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.