Custom Abutment AS Ti — Class II medical device recall Z-1633-2026
Ongoing recall by Straumann USA LLC, reported 2026-04-01, distributed nationwide. A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a r
| Recall number | Z-1633-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Straumann USA LLC, Andover, MA, United States |
| Recall initiated | 2026-03-17 |
| Classified | 2026-03-24 |
| Reported by FDA | 2026-04-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 7 units |
| UPC / GTIN / UDI-DI | 07630031773937 |
| Model numbers | 010.5438 |
Product
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1633-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.