Recall Z-1633-2026 ยท NHA Abutment, Implant, Dental, Endosseous
Straumann USA LLC
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
| Date | Mar 24, 2026 (initiated Mar 17, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 indi |
| Quantity | 7 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243278 | Custom Abutments Institut Straumann AG, Feb 21, 2025 |