# FDA recall Z-0513-2022

> **Straumann USA LLC** · Class II · device recall initiated 2021-11-30.

## Product

Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5  Article Number: 138.107

## Reason for recall

Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant

## Distribution

US Nationwide Distribution in the states of FL, IL, OH

## Key facts

- **Recall number:** Z-0513-2022
- **Recalling firm:** Straumann USA LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-30
- **Report date:** 2022-01-26
- **Termination date:** 2025-02-05

- **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-0513-2022

## Citation

> AI Analytics. FDA recall Z-0513-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0513-2022. Source: US FDA. Licensed CC0.

---

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