Recall Z-2534-2020— Dufner Instrumente GmbH
Class II · Terminated
Class II FDA medical device recall by Dufner Instrumente GmbH, initiated 2020-06-03, terminated 2021-01-21. FDA's recall record names no specific 510(k) clearance for this event. 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: 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.
- Recalling firm
- Dufner Instrumente GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-03
- Terminated
- 2021-01-21
- Firm location
- Tuttlingen, Germany
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.