# FDA recall Z-1633-2026

> **Straumann USA LLC** · Class II · device recall initiated 2026-03-17.

## 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.

## Distribution

Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada.

## Key facts

- **Recall number:** Z-1633-2026
- **Recalling firm:** Straumann USA LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-17
- **Report date:** 2026-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1633-2026

## Citation

> AI Analytics. FDA recall Z-1633-2026. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1633-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*