# FDA recall Z-2146-2023

> **Aesculap Implant Systems LLC** · Class II · device recall initiated 2023-05-18.

## Product

Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable  Article Number: MD610

## Reason for recall

Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.

## Distribution

US Nationwide distribution in the states of DC, MO, PA, TX.

## Key facts

- **Recall number:** Z-2146-2023
- **Recalling firm:** Aesculap Implant Systems LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-18
- **Report date:** 2023-07-26

- **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-2146-2023

## Citation

> AI Analytics. FDA recall Z-2146-2023. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-2146-2023. Source: US FDA. Licensed CC0.

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