# FDA recall Z-2814-2020

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2020-07-14.

## Product

Smart Stapes Protheses Piston  0.6mm X 4.25 mm- Partial Ossicular Replacement    Catalog Number: 70143662

## Reason for recall

Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below

## Distribution

CA , FL , GA , PA   Foreign: New Zealand , Switzerland

## Key facts

- **Recall number:** Z-2814-2020
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-14
- **Report date:** 2020-08-26
- **Termination date:** 2021-09-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2814-2020

## Citation

> AI Analytics. FDA recall Z-2814-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2814-2020. Source: US FDA. Licensed CC0.

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