Straumann USA LLC recalls Custom Abutment Ti

A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.

Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;

On March 17, 2026, Urgent Field Safety Action letters were sent to customers. Action to be taken: 1. Check your inventory for the affected article/project numbers. 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 Jennifer Jackson at Straumann USA, LLC for replacement as indicated on the Customer Confirmation Form. 4. If you have used the custom abutment, no action regarding patient treatment is required. Complete the Customer Confirmation Form indicating the product has been used. Should you determine that a remake is warranted, please contact Jennifer Jackson at jennifer.jackson@straumann.com to arrange for a remake. 6. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided. If product is not being returned, the completed Customer Confirmation Form can be scanned and emailed to jennifer.jackson@straumann.com 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.

• FDA enforcement recordOfficial FDA database entry for Z-1632-2026
• FDA 510(k) clearance · K072151The device's official FDA premarket clearance record
• FDA device classification · NHAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 872.3630The 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.