# FDA recall Z-1863-2025

> **Straumann USA LLC** · Class II · device recall initiated 2025-05-01.

## Product

GM Helix Acqua Implant, Article Number: 140.985

## Reason for recall

It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.

## Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, UAE, United Kingdom, Vietnam.

## Key facts

- **Recall number:** Z-1863-2025
- **Recalling firm:** Straumann USA LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-01
- **Report date:** 2025-06-04

- **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-1863-2025

## Citation

> AI Analytics. FDA recall Z-1863-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1863-2025. Source: US FDA. Licensed CC0.

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