# FDA recall Z-2308-2026

> **Grace Medical, Inc.** · Class II · device recall initiated 2026-04-03.

## Product

TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L    Model/Catalog Number: 409-375      Product Description: Stapes Prosthesis

## Reason for recall

Due to incorrect functional length on device labeling.

## Distribution

U.S Nationwide distribution in the state of MD.

## Key facts

- **Recall number:** Z-2308-2026
- **Recalling firm:** Grace Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-03
- **Report date:** 2026-06-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bartlett, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2308-2026

## Citation

> MORVS. FDA recall Z-2308-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/Z-2308-2026. Source: US FDA. Licensed CC0.

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