# FDA recall Z-2534-2020

> **Dufner Instrumente GmbH** · Class II · device recall initiated 2020-06-03.

## Product

DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures      Reference Number: 18044-23

## Reason for recall

Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury

## Distribution

IL

## Key facts

- **Recall number:** Z-2534-2020
- **Recalling firm:** Dufner Instrumente GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-03
- **Report date:** 2020-07-15
- **Termination date:** 2021-01-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tuttlingen, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2534-2020

## Citation

> AI Analytics. FDA recall Z-2534-2020. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-2534-2020. Source: US FDA. Licensed CC0.

---

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