Tuttlingen, Germany
Dufner Instrumente GmbH recalls
1 recall recorded since 2018, most recently on 3 June 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 3 June 2020
- Terminated
- 21 January 2021
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2534-2020
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.